[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"iga-nephropathy-igan\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:iga-nephropathy-igan":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,43,74,101,123,144,167,188,219,243,262,283,304,326,351,371,392,416,435,456,477,496,524,546,569],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100587273","resistance-of-iga-nephropathy-to-conventional-and-newly-approved-therapies-an-observational-real-life-study-resigan-100587273",false,"NCT06926244","RESistance of IgA Nephropathy to Conventional and Newly-approved Therapies: an Observational, Real-life Study (RESIGAN)","RESIGAN","Inclusion Criteria:\n\n* Adult patient: age ≥ 18 years\n* Renal biopsy performed after 2017 showing IgA deposits leading to the diagnosis of IgAN (the date of diagnosis being the index date)\n* Informed patient and who does not object to the use of his data\n\nExclusion Criteria:\n\n\\- None","ALL","18 Years",{"count":20,"type":21},800,"ESTIMATED","OBSERVATIONAL","IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide, characterized by glomerular mesangial IgA deposits, often with IgG and C3. Despite its prevalence, the pathophysiology of IgAN is poorly understood. The prognosis varies significantly, from benign hematuria to rapidly progressive glomerulonephritis, potentially leading to end-stage renal disease within months. The MEST-C classification enhances prognosis characterization and informs integrated scoring systems; however, while useful for assessing overall prognosis, these scores do not reliably predict treatment responses and are unvalidated for IgA vasculitis nephritis. Given the disease's heterogeneity, treatment options for IgAN, with or without vasculitis, are controversial. Nephroprotective strategies that lower intraglomerular pressure through RAS blockade are essential in managing IgAN. Steroids are considered for rapidly progressive cases, yet their effectiveness in persistent proteinuria despite optimized nephroprotection is debated. Other immunosuppressive therapies, such as B cell targeting and complement inhibition, are under investigation. Recently developed nephroprotective strategies, including SGLT2 inhibitors and endothelin-1 receptor antagonists, may significantly influence future therapeutic approaches. Although available in many European countries, their real-world effectiveness has not been evaluated. Identifying factors linked to persistent proteinuria and renal dysfunction despite optimized nephroprotection is a critical unmet need. We hypothesize that innovative nephroprotective strategies will reduce the risk of persistent proteinuria and renal dysfunction in an IgAN cohort.",[25],"IgA Nephropathy (IgAN)",[27,28,29],"IgAN","Primary Glomerulonephritis","Mesangial IgA Deposits","RECRUITING","2026-06-19",{"date":33,"type":34},"2026-06-23","ACTUAL",{"date":36,"type":34},"2025-06-23",{"date":38,"type":21},"2029-04",{"name":40,"class":41},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100592125","phase-2-phase-2-study-of-adx-038-in-complement-mediated-kidney-disease-100592125","NCT06989359","Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease","A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease","Inclusion Criteria:\n\n* Mean eGFR greater than or equal to 30 mL\u002Fmin\u002F1.73m2\n* Clinical evidence of active kidney disease\n* Treated with supportive care including an ACE inhibitor or ARB if applicable\n* Willing to receive required vaccinations\n* Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy\n\nExclusion Criteria:\n\n* Hereditary or acquired complement deficiency\n* Kidney transplant or renal replacement therapy\n* History of solid organ transplant\n* Other kidney disease\n* History of recurrent invasive infections\n* Received complement inhibitor treatments\n* Active systemic viral, bacterial, or fungal infection\n* Abnormal liver function",{"count":51,"type":21},45,"INTERVENTIONAL",[54],"PHASE2","This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.",[27,57,58,25,59],"C3G","Complement-mediated Kidney Disease","IC-MPGN",[61,27,57,59,62],"IgA Nephropathy","complement-mediated kidney disease","2026-06-12",{"date":65,"type":34},"2026-06-16",{"date":67,"type":34},"2025-08-28",{"date":69,"type":21},"2029-06",{"name":71,"class":72},"ADARx Pharmaceuticals, Inc.","INDUSTRY",29,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":42},"100642333","mediators-of-loin-pain-in-iga-nephropathy-100642333","NCT07649538","Mediators of Loin Pain in IgA Nephropathy","LO-PAIgN: Mediators of Loin Pain in Immunoglobulin-A Nephropathy","LO-PAIgN","Inclusion Criteria:\n\nCohort A\n\n1. ≥18 years of age at the time of recruitment\n2. IgAN diagnosis confirmed with a renal biopsy\n3. Episodic\u002FIntermittent Loin Pain (defined as pain at least once every 6 months)\n4. Have the capacity to consent to the study Cohort B\n\n1\\) ≥18 years of age at the time of recruitment 2) IgAN diagnosis confirmed with a renal biopsy 3) No history of loin pain 4) Have the capacity to consent to the study\n\nExclusion Criteria:\n\nCohort A\n\n1. Constant loin pain\n2. Infrequent loin pain (no pain experienced in the last 6 months)\n3. Inability to differentiate loin pain from back pain\n4. Other renal diseases\n5. Therapies that interfere with immune-mediation like steroids and complement inhibitors\n6. Kidney transplant recipients\n7. Current participation in an interventional study that may affect kidney function\n8. Patients on dialysis\n9. Patients with implants that are not MRI-safe (pacemakers, implantable defibrillators, cochlear implants, some shunts, neurostimulators, some aneurysm clips, etc.)\n\nCohort B\n\n1. Other renal diseases\n2. Therapies that interfere with immune-mediation like steroids and complement inhibitors\n3. Kidney transplant recipients\n4. Current participation in an interventional study that may affect kidney function\n5. Patients on dialysis\n6. Patients with conditions\u002Fimplants that are not MRI-compatible (claustrophobia, pacemakers, implantable defibrillators, cochlear implants, some shunts, neurostimulators, some aneurysm clips, etc.)",{"count":83,"type":21},40,"The goal of this observational study is to learn about loin pain in people with Immunoglobulin A nephropathy (IgAN).\n\nThe main question it aims to answer is:\n\nWhat changes occur in the kidneys, urine, and blood when people with IgAN experience loin pain?\n\nParticipants will have MRI scans of their kidneys, provide urine and blood samples, and have their latest kidney function test results reviewed. For participants who experience loin pain, these assessments will be carried out during a pain episode and again when they are pain-free, so the results can be compared.",[25],[87,27,88,89,90,91],"Kidney pain","IgA nephropathy","Flank pain","Loin pain","Renal pain","NOT_YET_RECRUITING","2026-06-09",{"date":65,"type":34},{"date":96,"type":21},"2026-08-20",{"date":98,"type":21},"2028-06-02",{"name":100,"class":41},"University of Leicester",{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":52,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100637065","phase-2-a-study-to-evaluate-the-long-term-safety-and-efficacy-of-hsk39297-tablets-in-primary-iga-nephropathy-100637065","NCT07616700","A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy","A Multicenter, Open-Label Phase II Clinical Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in the Treatment of Primary IgA Nephropathy","Inclusion Criteria:\n\n1. Completed the HSK39297-202 study and assessed by the investigator to have a favorable benefit-risk profile for 200 mg QD HSK39297.\n2. eGFR ≥30 mL\u002Fmin\u002F1.73 m² at screening (calculated by CKD-EPI 2021 equation).\n3. Able to maintain optimized, stable background therapy with RAS blockers, SGLT2 inhibitors, endothelin receptor antagonists, or hydroxychloroquine during the study.\n4. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required in the previous study (booster if needed).\n5. Fertile females: negative serum pregnancy test; highly effective contraception from signing informed consent until 30 days after last dose.\n\n   Fertile males: highly effective contraception from signing informed consent until 90 days after last dose.\n6. Voluntarily provided written informed consent and able to comply with study procedures\n\nExclusion Criteria:\n\n1. Known or suspected hereditary or acquired complement deficiency.\n2. Active primary or secondary immunodeficiency.\n3. History of bone marrow \u002F hematopoietic stem cell or solid organ transplantation.\n4. Malignancy within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).\n5. History of recurrent invasive infections caused by encapsulated bacteria (e.g., N. meningitidis, S. pneumoniae) or Mycobacterium tuberculosis.\n6. Severe concomitant diseases judged by the investigator to be incompatible with study participation.\n7. Suspected hypersensitivity to the investigational product or its class.\n8. Pregnant or lactating females.\n9. Other conditions that may interfere with the study or increase subject risk.",{"count":109,"type":21},73,[54],"This is a Phase II, multicenter, open-label study. Eligible subjects who have completed the HSK39297-202 study will be enrolled.Starting dose is 200 mg QD.Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \\>1 g\u002F24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.After the treatment period, subjects will enter the 4-week safety follow-up period.",[25],"2026-05-27",{"date":115,"type":34},"2026-06-01",{"date":117,"type":34},"2025-08-25",{"date":119,"type":21},"2026-12-26",{"name":121,"class":72},"Haisco Pharmaceutical Group Co., Ltd.",2,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":52,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100622938","phase-3-phase--study-of-efficacy-and-safety-of-hsk39297-tablet-in-treatment-of-patients-with-primary-igan-100622938","NCT07390123","Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN","A Randomized, Double-blind, and Placebo-controlled Parallel Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients With Primary IgAN","Inclusion Criteria:\n\n1. Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form.Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.\n2. Female and male patients above 18 years of age.\n3. Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) below 35 kg\u002Fm2. BMI = Body weight (kg) \u002F \\[Height (m)\\]2\n4. Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years.\n5. 24h-UPCR ≥0.75g\u002Fg or 24h-UPE≥1.0g\u002F24h at screening.\n6. Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL\u002Fmin per 1.73 m2.For patients with eGFR\\* 20 to \\\u003C30ml\u002Fmin\u002F1.73m2, a qualifying biopsy performed in two years.\n\nExclusion Criteria:\n\n1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.\n2. All transplanted patients (any organ, including bone marrow).\n3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer).\n4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.\n5. Pregnant or nursing (lactating) women.\n6. Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.",{"count":131,"type":21},370,[133],"PHASE3","Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN",[25],{"date":137,"type":34},"2026-05-28",{"date":139,"type":34},"2026-04-07",{"date":141,"type":21},"2028-07",{"name":121,"class":72},9,{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":52,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":122},"100640089","phase-2-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-ever001-in-participants-with-selected-proteinuric-glomerular-diseases-100640089","NCT07614477","Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases","The Sub-Study 3 of A Phase 1b\u002F2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases (ES108001)","Inclusion Criteria:\n\n* Primary FSGS or MCD\u002FIgAN confirmed by renal biopsy\n* eGFR ≥ 45 mL\u002Fmin\u002F1.73 m²\n* For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) \\> 3.5 g\u002Fg and serum albumin \\\u003C 30 g\u002FL during the screening period\n* For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g\u002Fg; ARB or ACEI stable for ≥ 12 weeks prior to Day 1\n* Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment\n\nExclusion Criteria:\n\n* Hereditary or secondary FSGS\u002FMCD; collapsing FSGS\n* BMI ≥ 35 kg\u002Fm² in participants with FSGS\u002FMCD\n* Evidence of diabetes mellitus or a history of diabetes mellitus\n* Acute or chronic infection requiring treatment\n* Patients infected with HIV, hepatitis C, syphilis, or hepatitis B\n* Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB\n* At risk of bleeding\n* Baseline 24-hour UPCR \\> 3 g\u002Fg and serum albumin \\\u003C 30 g\u002FL in participants with IgAN","75 Years",{"count":51,"type":21},[54],"This is a Phase 1b\u002F2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at \\~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.",[156,25,157],"Minimal Change Disease (MCD)","Focal Segmental Glomerulosclerosis (FSGS)","2026-05-22",{"date":160,"type":34},"2026-05-29",{"date":162,"type":21},"2026-05-15",{"date":164,"type":21},"2029-03-31",{"name":166,"class":72},"Everest Medicines (China) Co.,Ltd.",{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":52,"phases":176,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100637504","phase-4-efficacy-and-safety-of-nefecon-on-prevention-of-relapse-of-iga-nephropathy-a-randomized-double-blinded-placebo-controlled-trial-100637504","NCT07604311","Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy: a Randomized, Double-blinded, Placebo-Controlled Trial","NeFRIN","Inclusion Criteria:\n\n* Diagnosed primary IgAN with biopsy verification.\n* Female or male participants ≥18 years of age.\n* Completion of 9 months of Nefecon 16 mg QD at the Baseline visit.\n* Proteinuria ≥ 1g\u002Fd prior to initiation of Nefecon\n* Proteinuria\\\u003C0.5 g\u002Fday (or UPCR \\\u003C0.5 g\u002Fg) at screening\n* eGFR ≥30 ml\u002Fmin\u002F1.73m² at screening\n* On stable treatment with supportive treatment（including RAASi, SGLT2i, ERA） for at least 1 month prior to the Baseline visit\n\nExclusion Criteria:\n\n* Systemic diseases that may cause mesangial immunoglobulin A deposition, including but not limited to IgAVN, systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis, and others;\n* Presence of other glomerulopathies (e.g., C3 glomerulopathy, nephrotic syndrome and\u002For diabetes nephropathy), active infection, severe hepatic impairment (Child-Pugh Class C), congestive heart failure, and a history of malignant tumor within the past 5 years.\n* On current or planned dialysis or kidney transplantation;\n* Participants who have been treated with systemic glucocorticoids and immunosuppressive agents within the past 3 months, including mycophenolate mofetil, hydroxychloroquine, cyclophosphamide, azathioprine, leflunomide, calcineurin inhibitors, and Chinese traditional medicines with immunosuppressive effects (such as Tripterygium wilfordii, Sinomenium acutum, Tripterygium Glycosides Tablets, Kunxian Capsules, Kunming Shanhaitang Tablets, etc.); treatment with B-cell targeted biological agents (such as telitacicept, etc.); complement pathway inhibitors, etc.;\n* Poorly controlled diabetes mellitus (HbA1c\\>8%）\n* Poorly controlled hypertension （≥160\u002F100mmHg）\n* Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4.\n* Females who are pregnant, breastfeeding, or plan to become pregnant in the trial period.\n* Any other conditions that, in the investigator's judgment, make the patient ineligible for this clinical study.",{"count":175,"type":21},288,[177],"PHASE4","IgA nephropathy (IgAN) is a chronic progressive kidney disease, and long-term control of proteinuria and prevention of relapse are crucial for delaying disease progression. Patients with IgAN who achieve proteinuria remission after receiving Nefecon for 9 months or longer still face the risk of proteinuria relapse after treatment discontinuation. This study is to evaluate the efficacy and safety of Nefecon 8 mg treatment for 15 months as a maintenance therapy for prevention of proteinuria relapse in proteinuria-remitted patients.",[25],"2026-05-18",{"date":158,"type":34},{"date":183,"type":21},"2026-05-01",{"date":185,"type":21},"2028-12-31",{"name":187,"class":41},"Nanfang Hospital, Southern Medical University",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":52,"phases":198,"briefSummary":200,"conditions":201,"keywords":207,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":42},"100639684","early-phase-1-cd19bcma-ucar-t-for-b-cell-related-autoimmune-disease-100639684","NCT07586267","CD19\u002FBCMA UCAR-T for B Cell-Related Autoimmune Disease","An Exploratory Clinical Study Evaluate the Safety and Efficacy of Universal Universal Allogeneic CAR-T Cells Targeting CD19 and BCMA in the Treatment of B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n\n  1. Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n  2. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n  3. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n  4. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n  5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n\n  1. Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n  2. Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n  3. SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both)；Patients with severe refractory SLE-ITP, characterized by a platelet count of \\\u003C30×10⁹\u002FL or \\\u003C50×10⁹\u002FL accompanied by bleeding tendency, regardless of the SLEDAI-2K score.\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Telitacicept or rituximab).\n  2. if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n  3. Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n  4. Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n  1. Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n  2. \\>50% decline in eGFR within 3 months;\n  3. Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n  2. Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n  3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ;or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.","3 Years",{"count":197,"type":21},15,[199],"EARLY_PHASE1","This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[202,203,204,25,205,206],"Autoimmune Diseases","Systemic Lupus Erthematosus (SLE)","Multi-Drug Resistant Nephrotic Syndrome","Systemic Sclerosis (SSc)","ANCA Associated Systemic Vasculitis",[208,204,203,25,205,209],"UCART","ANCA associated systemic vasculitis","2026-05-12",{"date":212,"type":34},"2026-05-14",{"date":214,"type":21},"2026-05-08",{"date":216,"type":21},"2030-12-31",{"name":218,"class":41},"The Children's Hospital of Zhejiang University School of Medicine",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":151,"enrollmentInfo":225,"targetDuration":4,"studyType":52,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":42},"100622890","early-phase-1-a-clinical-study-evaluating-the-safety-and-efficacy-of-gt719-universal-cell-injection-in-the-treatment-of-immune-mediated-kidney-diseases-100622890","NCT07389499","A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases","Inclusion Criteria:\n\n* 1\\. The participant or their legal representative voluntarily signs a written informed consent form, and is willing and able to comply with the procedures of this study.\n* 2\\. Aged 18 to 75 years (inclusive) at the time of signing the informed consent, regardless of gender.\n* 3\\. Positive expression of CD19 on B cells in peripheral blood is confirmed by flow cytometry.\n* 4\\. Participants with IgA nephropathy (IgAN) at high risk of progression:\n\n  ① A definite pathological diagnosis of IgAN confirmed by renal biopsy (renal biopsy must be performed within 2 years prior to screening or during the screening period).\n  * Meet at least one of the following requirements:\n\n    1. Prior treatment with glucocorticoids, budesonide enteric-coated capsules, immunosuppressants (including mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, Tripterygium wilfordii, leflunomide, azathioprine), or biological agents (including but not limited to anti-CD20 monoclonal antibodies, telitacicept, daratumumab) for a cumulative duration of at least 3 months, with persistent 24-hour urinary protein ≥ 0.75 g or UPCR ≥ 0.75 g\u002Fg.\n    2. The predicted probability of a 50% decline in eGFR or end-stage renal disease (ESRD) within 5 years calculated by the international IgAN prediction tool is ≥ 20%.\n    3. A ≥ 20% decline in eGFR within 3 months.\n    4. Renal biopsy performed within 6 months indicating Oxford classification C2 lesion.\n    5. Patients who are intolerant to conventional treatment and for whom the investigator determines that the benefits outweigh the risks, with adequate informed consent obtained, may be considered for inclusion.\n* 5\\. Participants with ANCA-associated vasculitis (AAV)\u002FANCA-associated glomerulonephritis (AAGN) must meet the following criteria:\n\n  ① Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis.\n\n  ② Positive anti-myeloperoxidase (MPO-ANCA) antibody or anti-proteinase 3 (PR3-ANCA) antibody detected during screening or in previous tests.\n\n  ③ AAGN: Availability of a renal biopsy pathological report within 2 years; if eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m², a renal biopsy pathological report obtained during the screening period is required. Presence of active lesions according to the 2010 Berden classification criteria for AAGN.\n\n  ④ Renal-uninvolved AAV: Birmingham Vasculitis Activity Score (BVAS) version 3.0 ≥ 3 points, indicating active vasculitis.\n\n  ⑤ Failure of standard of care (SOC), defined as any of the following:\n\n  a) Failure to achieve remission after at least 3 months of treatment with glucocorticoids combined with cyclophosphamide or rituximab.\n\n  b) Disease relapse after achieving remission. c) Persistent disease activity despite receiving SOC for at least 6 months, including glucocorticoids, cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as other biological agents (including but not limited to mepolizumab) or avacopan.\n* 6\\. Participants with membranous nephropathy (MN) must meet the following criteria:\n\n  * Definite pathological diagnosis of primary (idiopathic) MN confirmed by renal biopsy (renal biopsy must be performed within 2 years prior to screening or during the screening period).\n\n    ② Elevated serum anti-PLA2R antibody titer detected during screening or in previous tests, or positive PLA2R antigen staining in renal tissue.\n\n    ③ eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².\n\n    ④ Meeting the criteria for high-risk or relapsed\u002Frefractory MN: c) High-risk patients, defined as meeting any of the following: Normal eGFR, urinary protein \\> 3.5 g\u002F24h, \\\u003C 50% reduction in urinary protein after 6 months of ACEI\u002FARB treatment, and serum albumin \\\u003C 25 g\u002FL or anti-PLA2R antibody \\> 50 RU\u002FmL.\n\neGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m² and\u002For urinary protein \\> 8 g\u002F24h for more than 6 months.\n\nd) Relapsed\u002Frefractory patients: Relapsed patients: Defined as achieving complete or partial remission with previous SOC treatment, followed by recurrence of urinary protein ≥ 3.5 g\u002F24h.\n\nRefractory patients: Defined as refractory to previous SOC treatment (persistent urinary protein ≥ 3.5 g\u002F24h with \\\u003C 50% reduction compared to baseline).\n\n* 7\\. Participants with refractory podocytopathy:\n\n  ① Pathological diagnosis of minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) confirmed by renal biopsy (renal biopsy must be performed within 2 years prior to screening or during the screening period).\n\n  ② Meet at least one of the following requirements:\n  1. Previous diagnosis of steroid-resistant nephrotic syndrome (SRNS): 24-hour urinary protein \\> 3 g or UPCR ≥ 3.5 g\u002Fg, serum albumin \\\u003C 30 g\u002FL, failure to achieve complete remission after 4 weeks of standard-dose glucocorticoid treatment.\n  2. Previous diagnosis of steroid-dependent nephrotic syndrome (SDNS): Remission achievable with glucocorticoid treatment, but relapse within 2 weeks of glucocorticoid tapering or discontinuation, or two consecutive relapses during glucocorticoid tapering.\n  3. Previous diagnosis of frequently relapsing nephrotic syndrome (FRNS): ≥ 3 relapses within 1 year or ≥ 2 relapses within 6 months after achieving complete remission with glucocorticoid treatment.\n  4. Previous treatment with one immunosuppressant (including cyclosporine A, tacrolimus, mycophenolate mofetil, cyclophosphamide) or biological agent (including but not limited to anti-CD20 monoclonal antibodies, telitacicept, daratumumab) for ≥ 6 months without achieving remission or with intolerance.\n  5. Failure to achieve remission within 6 months of adequate treatment with one immunosuppressant or biological agent, but the investigator judges that the benefits outweigh the risks and the patient has provided full informed consent, the patient may be considered for inclusion.\n* 8\\. Participants with proliferative glomerulonephritis with monoclonal immunoglobulin deposition (PGNMID):\n\n  * Definite pathological diagnosis of PGNMID confirmed by renal biopsy (renal biopsy must be performed within 3 years prior to screening or during the screening period).\n\n    * Meet at least one of the following requirements:\n\nPersistent 24-hour urinary protein ≥ 1 g or UPCR ≥ 1 g\u002Fg despite treatment with angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 4 weeks.\n\neGFR ≥ 30 mL\u002Fmin\u002F1.73 m² with progressive decline (≥ 20% decrease in eGFR) within the recent 6-12 months.\n\nDevelopment of nephrotic syndrome or nephrotic-range proteinuria (24-hour urinary protein ≥ 3 g or UPCR ≥ 3 g\u002Fg) without stable remission with short-term glucocorticoid treatment.\n\n③ Exclusion of hematological malignancies (leukemia, lymphoma, multiple myeloma, systemic light chain amyloidosis) by bone marrow aspiration and biopsy (bone marrow aspiration must be performed within 6 months prior to screening or during the screening period).\n\n* 9\\. Screening laboratory test results must meet the following criteria (excluding indicators related to the study disease):\n\n  1. Neutrophil count ≥ 1.5 × 10⁹\u002FL;\n  2. Hemoglobin ≥ 80 g\u002FL; Platelet count ≥ 50 × 10⁹\u002FL;\n  3. Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤ 3 × ULN; Total bilirubin (TBIL) \\\u003C 2 × ULN (for participants with Gilbert syndrome, direct bilirubin (DBIL) ≤ 1.5 × ULN);\n  4. Creatinine clearance rate ≥ 30 mL\u002Fmin; (except for anti-GBM glomerulonephritis, AAV\u002FANCA-associated glomerulonephritis);\n  5. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; Prothrombin time (PT) ≤ 1.5 × ULN;\n  6. Left ventricular ejection fraction (LVEF) ≥ 50% diagnosed by echocardiography.\n  7. Pulmonary function: Defined as dyspnea ≤ CTCAE Grade 1 and oxygen saturation (SpO₂) ≥ 92% at rest while breathing room air (measured by pulse oximetry).\n* 10\\. Female participants of childbearing potential must:\n\n  a. Have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result at screening, confirmed by the investigator; b. Agree to avoid breastfeeding during study participation until at least 1 year after GT719 cell infusion or until GT719 cells are no longer detected by two consecutive flow cytometry tests, whichever is later.\n* 11\\. Male participants with sexual partners and female participants of childbearing potential must agree to use highly effective contraceptive methods (e.g., contraceptive pills, intrauterine devices, or condoms) starting from screening until at least 1 year after GT719 cell infusion or until GT719 cells are no longer detected by two consecutive flow cytometry tests, whichever is later. Male participants must agree to use condoms during sexual contact with pregnant women or women of childbearing potential for at least 1 year after GT719 cell infusion, even after successful vasectomy.\n\nExclusion Criteria:\n\n* 1\\. Participants with IgA nephropathy (IgAN) at high risk of progression:\n\n  a. Secondary IgAN (e.g., associated with active hepatitis B\u002Fhepatitis C infection, HIV, etc.).\n* 2\\. Participants with ANCA-associated vasculitis (AAV)\u002FANCA-associated glomerulonephritis (AAGN):\n\n  1. Drug-induced or secondary AAV\u002FAAGN.\n  2. Alveolar hemorrhage requiring invasive mechanical ventilation support at screening.\n* 3\\. Participants with membranous nephropathy (MN):\n\n  a. Secondary membranous nephropathy.\n* 4\\. Participants with refractory podocytopathy:\n\n  a. Hereditary podocytopathy and secondary focal segmental glomerulosclerosis (FSGS).\n* 5\\. Participants with proliferative glomerulonephritis with monoclonal immunoglobulin deposition (PGNMID):\n\n  1. Monoclonal deposition caused by secondary nephropathy (e.g., those diagnosed with multiple myeloma or severe systemic lymphoplasmacytic disease requiring immediate oncological treatment).\n\nFor all participants:\n\n* 6\\. History of severe hypersensitivity reaction or allergy.\n* 7\\. Contraindication or hypersensitivity to fludarabine, cyclophosphamide, or any component of the investigational product.\n* 8\\. Currently receiving renal replacement therapy or expected to require renal replacement therapy during the study period.\n* 9\\. Rapidly progressive glomerulonephritis unrelated to AAV\u002FAAGN, anti-GBM disease, MN, acute post-streptococcal nephritis (APSN), or IgG4-related kidney disease (IgG4-RKD), defined as a ≥ 50% decrease in eGFR within 3 months of diagnosis.\n* 10\\. History of other uncontrolled severe conditions not directly related to the study disease prior to screening, such as severe hemolytic anemia, severe immune thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe pneumonia or pulmonary hemorrhage, severe hepatitis, severe vasculitis, active central nervous system (CNS) symptoms including cerebrovascular accident, aneurysm, epilepsy, convulsion, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.\n* 11\\. History of the following cardiac diseases or conditions:\n\n  1. New York Heart Association (NYHA) Class III or IV congestive heart failure within 12 months prior to screening;\n  2. Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening;\n  3. History of clinically significant ventricular arrhythmia or unexplained syncope not caused by vasovagal response or dehydration, or corrected QT interval (QTc) \\> 480 ms at screening;\n  4. History of severe non-ischemic cardiomyopathy;\n  5. Pulmonary arterial hypertension, including secondary pulmonary arterial hypertension, with WHO functional class \\> 2;\n  6. QTcF \\> 450 msec in males and QTcF \\> 470 msec in females, based on the average QTcF (QT interval corrected by Fridericia's formula) value from a single ECG or three repeated ECGs performed at intervals of more than 3 minutes.\n* 12\\. Presence of significant pulmonary or cardiac manifestations (e.g., pericarditis, pleural effusion) at screening, which the investigator assesses may affect the participant's ability to receive treatment safely or tolerate treatment.\n* 13\\. Evidence of advanced fibrotic interstitial lung disease on chest CT, with the latest pulmonary function test showing forced vital capacity (FVC) \\\u003C 40% of predicted value or diffusing capacity of the lung for carbon monoxide (DLCO) \\\u003C 30% of predicted value.\n* 14\\. History of any active malignancy or malignant tumor within 5 years prior to screening. Exceptions include: early-stage tumors treated with radical therapy (carcinoma in situ or Stage I tumor, non-ulcerative primary melanoma with depth \\\u003C 1 mm and no lymph node involvement), cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast that has received potentially curative treatment.\n* 15\\. Clinically significant bleeding symptoms or definite bleeding tendency within 6 months prior to screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; hereditary or acquired bleeding and thrombotic tendency (e.g., hemophilia, coagulation dysfunction, hypersplenism, etc.); occurrence of arteriovenous thrombotic events within 6 months prior to screening, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis, and\u002For pulmonary embolism.\n* 16\\. Presence of severe underlying medical conditions at screening, such as:\n\n  1. Evidence of uncontrolled viral, bacterial, fungal, or other infections requiring systemic intravenous treatment;\n  2. Obvious clinical evidence of dementia or altered mental status;\n  3. History of any other CNS disease or neurodegenerative disease, such as epilepsy, convulsion, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or psychosis.\n* 17\\. Positive results for any of the following tests:\n\n  1. Human immunodeficiency virus (HIV) antibody positive;\n  2. Hepatitis B surface antigen (HBsAg) positive; or hepatitis B core antibody (HBcAb) positive with hepatitis B virus (HBV)-DNA level above the lower limit of quantification (LLOQ) of the assay;\n  3. Hepatitis C virus (HCV) antibody positive with HCV RNA level above the LLOQ of the assay;\n  4. Syphilis antibody positive (excluding false-positive results caused by underlying diseases).\n* 18\\. H Positive results for cytomegalovirus (CMV) DNA or Epstein-Barr virus (EBV) DNA test.\n* 19\\. Active tuberculosis prior to screening or latent tuberculosis not receiving appropriate treatment.\n* 20\\. Receipt of other investigational drugs within 4 weeks prior to signing the informed consent form (ICF), or the interval between the ICF signing date and the last dose of the previous investigational drug trial is still within 5 half-lives of the drug, whichever is longer.\n* 21\\. Receipt of plasma exchange therapy or immunoadsorption therapy within 4 weeks prior to lymphodepletion conditioning.\n* 22\\. Receipt of B-cell-targeted drug therapy within 1 week prior to lymphodepletion conditioning, including but not limited to rituximab, obinutuzumab, belimumab, telitacicept, etc.\n* 23\\. Receipt of tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, etc., within 2 weeks prior to lymphodepletion conditioning.\n* 24\\. Receipt of neonatal Fc receptor (FcRn) antagonist therapy (e.g., efgartigimod, etc.) within 3 weeks prior to lymphodepletion conditioning.\n* 25\\. Receipt of complement inhibition therapy (e.g., eculizumab, etc.) within 3 weeks prior to lymphodepletion conditioning.\n* 26\\. Receipt of live attenuated vaccine within 4 weeks prior to lymphodepletion conditioning.\n* 27\\. Performance of major surgery within 8 weeks prior to screening, or planned surgery during the study period.\n* 28\\. History of organ transplantation.\n* 29\\. Previous receipt of CAR-T product therapy targeting any antigen (except for GT719 treatment).\n* 30\\. Presence of any condition that, in the investigator's judgment, would prevent the participant from completing the entire trial, confound trial results, or make trial participation not in the participant's best interest.\n* 31\\. Presence of donor-specific anti-HLA antibodies against GT719 cells.",{"count":226,"type":21},30,[199],"This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase. In the dose-escalation phase, approximately 9-18 adult participants with immune-mediated kidney diseases are planned to be enrolled and treated with GT719 universal cell injection. The objectives of this phase are to evaluate the safety and tolerability of the product, determine the recommended dose (RD) for subsequent studies, conduct a preliminary assessment of its clinical efficacy, and investigate the pharmacokinetic and pharmacodynamic characteristics. Upon completion of the dose-escalation phase, after evaluation by investigators and collaborators, an appropriate dose will be selected for the dose-expansion phase. An additional 12 participants will be enrolled to fully assess the safety and efficacy of the product.",[25,230,231,232,233],"Membranous Nephropathy","ANCA-associated Vasculitis (AAV)\u002FANCA-associated Glomerulonephritis (AAGN)","Refractory Podocytopathy","Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits","2026-04-22",{"date":236,"type":34},"2026-04-23",{"date":238,"type":21},"2026-05-30",{"date":240,"type":21},"2028-06-30",{"name":242,"class":72},"Grit Biotechnology",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":258,"leadSponsor":260,"locationsCount":42},"100635639","clinical-experience-with-sparsentan-in-switzerland-in-iga-nephropathy-100635639","NCT07555301","Clinical Experience With Sparsentan in Switzerland in IgA Nephropathy","SWIAN","Inclusion Criteria:\n\n* IgA Nephropathy, Use of Sparsentan\n\nExclusion Criteria:\n\n* age \\\u003C 18y",{"count":251,"type":21},50,"An observational study tracking the clinical course of patients with IgA nephropathy.",[25],"2026-04-21",{"date":256,"type":34},"2026-04-29",{"date":115,"type":21},{"date":259,"type":21},"2029-12-31",{"name":261,"class":41},"Waid City Hospital, Zurich",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":52,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":279,"leadSponsor":281,"locationsCount":42},"100635500","phase-2-sln12140-in-adult-participants-with-iga-nephropathy-in-china-100635500","NCT07553494","SLN12140 in Adult Participants With IgA Nephropathy in China","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SLN12140 in Adult Patients With Primary IgA Nephropathy","Inclusion Criteria:\n\n* The subject has fully understood the purpose, nature, methods and potential adverse reactions of this trial, volunteers to participate as a subject, is able to communicate effectively with the investigators, understands and complies with all requirements of this study, and voluntarily signs the Informed Consent Form (ICF) prior to initiation of any study procedures.\n* Male and female subjects aged 18 to 80 years (inclusive) at the time of signing the ICF, with body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) 18.0-35.0 kg\u002Fm² (inclusive).\n* Patients with IgA nephropathy confirmed by biopsy within the past 3 years before screening, with renal tubulointerstitial fibrosis \\\u003C 50%.\n* Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m² during the screening period, calculated using the 2021 creatinine-based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n* During the screening period, 24-hour urine protein-to-creatinine ratio (24h UPCR) ≥ 1.0 g\u002Fg; after completion of the run-in period, UPCR ≥ 0.75 g\u002Fg or urine protein excretion (UPE) ≥ 0.75 g\u002Fday.\n* Must have received standard of care therapy for at least 12 weeks (and at a stable dose for at least 4 weeks) prior to the first dose of study medication, and agree to maintain stable dosing throughout the study period. (Note: Permitted standard of care medications in this study include ACEi\u002FARB and SGLT2i.)\n* Males and women of childbearing potential (WOCBP; as defined by the Clinical Trials Facilitation and Coordination Group \\[CTFG\\] 2020) must agree to follow the contraception guidelines specified in the protocol from the screening period until 6 months after the last dose of study medication.\n* The subject is willing to receive quadrivalent meningococcal vaccine and pneumococcal vaccine at least 14 days before dosing (for subjects vaccinated within 14 days before dosing, antibiotic prophylaxis for at least 14 days is required after the first vaccination). Re-vaccination is not required for those who have received quadrivalent meningococcal vaccine within 3 years before the first dose, or pneumococcal vaccine within 5 years before the first dose.\n\nExclusion Criteria:\n\n* A known history of hypersensitivity, allergy, or anaphylactic reaction to any component of the investigational product, including hypersensitivity to human, humanized, or murine monoclonal antibodies, or known hypersensitivity to any ingredient of the product.\n* Secondary IgA nephropathy as determined by the investigator, such as that caused by Henoch-Schönlein purpura, systemic lupus erythematosus, hepatitis, ankylosing spondylitis, infection, or other etiologies.\n* Diagnosis of IgA vasculitis.\n* Current presence or history of nephrotic syndrome.\n* Clinical suspicion of IgA nephropathy with rapidly progressive glomerulonephritis in accordance with the Kidney Disease: Improving Global Outcomes (KDIGO) 2025 guidelines (≥50% decline in eGFR within 3 months prior to ICF signature, or a \\\u003C50% decline but at risk of rapid renal function deterioration as assessed by the investigator).\n* Clinical suspicion or biopsy-confirmed chronic kidney disease caused by any disease other than IgA nephropathy, including other glomerulopathies or podocytopathies.\n\nOther protocol-defined exclusion criteria may apply.","80 Years",{"count":271,"type":21},48,[54],"This study is a randomized, parallel, double-blind, placebo-controlled, subcutaneous administration Phase II dose-exploration clinical trial aimed at evaluating the efficacy, safety, PK, PD, and immunogenicity characteristics of SLN12140 at different doses in IgA nephropathy subjects who have previously received standard treatment (the standard treatment drugs allowed in this study include: angiotensin-converting enzyme inhibitors \\[ACEi\\], angiotensin II receptor blockers \\[ARB\\], and sodium-glucose co-transporter 2 inhibitors \\[SGLT2i\\]) but have poor control.\n\nThe study is divided into four stages, including a screening period of up to 8 weeks, an introduction period of up to 12 weeks, a 40-week double-blind period (including a 36-week treatment period and a 4-week safety follow-up period; all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will enter the open-label extension period for continued treatment after completing the double-blind period), and a 56-week open-label extension period (all subjects in the three dose groups who are willing to continue treatment and are judged by the investigator to potentially benefit from subsequent treatment will continue SLN12140 at the same dose group \\[the optimal dose\\], including a 52-week open treatment period and a 4-week safety follow-up period).",[25],"2026-04-20",{"date":277,"type":34},"2026-04-28",{"date":160,"type":21},{"date":280,"type":21},"2028-12",{"name":282,"class":72},"Linno Pharmaceuticals, Inc.",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":52,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":300,"leadSponsor":302,"locationsCount":42},"100634088","early-phase-1-efficacy-and-safety-of-cd19-car--t-cells-in-the-treatment-of-relapsedrefractory-autoimmune-nephropathy-100634088","NCT07535138","Efficacy and Safety of CD19 CAR-γδ T Cells in the Treatment of Relapsed\u002FRefractory Autoimmune Nephropathy","A Clinical Study on the Safety and Efficacy of CD19-Targeted Universal CAR-γδ T Cells in Relapsed\u002FRefractory Autoimmune Nephropathy","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n\n  1. Age ≥18 years and ≤65 years;\n  2. Agree to participate in this study and sign the informed consent form;\n  3. Major organ function must meet the following criteria (exceptions are allowed for abnormalities associated with active autoimmune diseases):\n\n     1. Liver function: ALT, AST or ALP level ≤3 × ULN (upper limit of normal), bilirubin ≤2 × ULN;\n     2. Renal function: eGFR ≥30 mL\u002Fmin\u002F1.73m²;\n     3. Pulmonary function: blood oxygen saturation (without oxygen inhalation) ≥92%;\n     4. Cardiac function: hemodynamically stable, left ventricular ejection fraction (LVEF) ≥55%;\n     5. Peripheral blood function: neutrophil count ≥1×10\\^9\u002FL, hemoglobin ≥60 g\u002FL, platelets ≥30×10\\^9\u002FL;\n  4. Subjects of childbearing potential (including males and females) must agree to use medically acceptable effective contraceptive measures during the study period and for at least 1 year after CAR-T cell infusion.\n* Primary Membranous Nephropathy:\n\n  1. Diagnosed with primary membranous nephropathy (PMN) by renal biopsy within 18 months before screening;\n  2. Meet the current clinical criteria for refractory PMN: after 6 months of systemic treatment with immunosuppressive regimens recommended by the KDIGO guidelines (including steroids, cyclophosphamide, calcineurin inhibitors, anti-CD20 monoclonal antibodies, etc.), persistent 24-hour urinary protein ≥3.5g and not reduced to less than 50% of the baseline level;\n  3. Relapsed PMN: after achieving complete or partial remission with the above immunosuppressive regimens, 24-hour urinary protein re-elevated to ≥ 3.5g.\n* Lupus Nephritis:\n\n  1. Diagnosed with systemic lupus erythematosus (SLE) before screening, in accordance with the 2019 EULAR\u002FACR classification criteria for systemic lupus erythematosus;\n  2. Diagnosed with lupus nephritis (LN) by renal biopsy within 18 months before screening, with pathological classification consistent with ISN\u002FRPS lupus nephritis class III\u002FIV (with or without class V);\n  3. SLEDAI-2000 score ≥6 at screening with at least 1 A grade or at least 2 B grades in the BILAG 2004 index; or SLEDAI-2000 score ≥8 at screening;\n  4. Meet the current clinical criteria for refractory LN: after standardized full-dose and full-course high-dose glucocorticoid plus hydroxychloroquine therapy combined with at least 2 immunosuppressive agents of different mechanisms (cyclophosphamide, mycophenolate mofetil, calcineurin inhibitors, etc.), or 1 immunosuppressive agent plus 1 biologic agent (belimumab, anti-CD20 monoclonal antibody, telitacicept, etc.), meet either of the following: ① After 3 months of standardized treatment, 24-hour urinary protein ≥1.5g and not reduced to less than 50% of baseline; ② After 6 months of standardized treatment, prednisone (or equivalent) cannot be tapered to 5 mg\u002Fday;\n  5. Relapsed LN: after achieving complete or partial remission with induction remission therapy, disease activity re-increased during maintenance therapy, requiring re-adjustment of the treatment regimen (including increasing glucocorticoid dose or re-initiating induction remission therapy).\n* IgA Nephropathy:\n\n  1. Diagnosed with IgA nephropathy by renal biopsy within 18 months before screening;\n  2. Meet the current clinical criteria for refractory IgA nephropathy: on the basis of standardized ACEI\u002FARB treatment, after 6 months of systemic immunosuppressive therapy recommended by the KDIGO guidelines (steroids, immunosuppressants, biologics), 24-hour urinary protein ≥0.5g and not reduced to less than 50% of baseline, or eGFR decreased by more than 50% within 3 months;\n  3. Two consecutive 24-hour urinary protein measurements \\> 0.5g with an interval of ≥ 2 weeks after achieving clinical remission with the above immunosuppressive therapy.\n\nExclusion Criteria:\n\n1. Subjects with life-threatening conditions (e.g., catastrophic antiphospholipid syndrome, acute severe renal failure) assessed by the investigator as unsuitable for enrollment in this study;\n2. History of alcohol or drug abuse within 24 weeks prior to screening;\n3. History of malignant tumors other than B-cell lymphoma, except for the following: malignancies confirmed to be cured or in remission for ≥5 years, radically resected basal cell carcinoma or squamous cell carcinoma of the skin, and carcinoma in situ at any site;\n4. Major surgery (including joint surgery) within 24 weeks prior to screening, or planned surgery within 24 weeks after enrollment;\n5. Complicated with overlapping mixed connective tissue disease, or other diseases that affect the assessment of disease activity;\n6. Active hepatitis B or hepatitis C virus infection, defined as: subjects positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with peripheral blood high-sensitivity HBV DNA quantification above the lower limit of detection; subjects with peripheral blood high-sensitivity HBV DNA quantification below the lower limit of detection may be enrolled only if the investigator provides appropriate prophylactic antiviral therapy; individuals positive for hepatitis C virus (HCV) antibody with positive peripheral blood high-sensitivity HCV RNA quantification;\n7. Coinfection with human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV), Treponema pallidum, cytomegalovirus (CMV), or complicated with selective IgA deficiency;\n8. Uncontrolled active infection (e.g., active pulmonary tuberculosis, etc., excluding simple urinary tract infection and bacterial pharyngitis); prophylactic administration of antibiotics, antiviral or antifungal agents is permitted;\n9. Clinical signs of herpes or varicella-zoster virus infection (especially varicella, herpes zoster) within 12 weeks prior to screening;\n10. History of major cardiovascular diseases within 6 months prior to screening, including NYHA class III or IV heart failure, myocardial infarction, angioplasty or stenting, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant cardiac diseases;\n11. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening;\n12. Central nervous system disorders caused by autoimmune or non-autoimmune diseases (including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis);\n13. Pregnant or lactating women;\n14. Hypersensitivity to any component of the CAR-γδ T cell product (including fludarabine, cyclophosphamide, tocilizumab);\n15. Administration of live vaccines within 6 weeks prior to the start of conditioning therapy;\n16. Participation in other clinical trials within 3 months prior to screening;\n17. Any other conditions deemed by the investigator to render the subject ineligible for enrollment in this clinical trial.","65 Years",{"count":197,"type":21},[199],"This study is a single-arm, single-center, open-label, dose-escalation exploratory clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of CD19 CAR-γδ T cells. The subjects enrolled in this study are patients with relapsed\u002Frefractory autoimmune nephropathy, including lupus nephritis, IgA nephropathy, and membranous nephropathy. This study adopts a standard \"3+3\" design to assess the recommended dose (RD) and identify dose-limiting toxicities (DLTs). The treatment process is as follows: subjects who meet the inclusion criteria will receive lymphodepletion conditioning, followed by a single intravenous infusion of CD19 CAR-γδ T cells. The primary objective of this study is to evaluate the safety profile of this cellular therapy, including the incidence of DLTs, maximum tolerated dose (MTD) or RD, as well as the incidence and severity of treatment-related adverse events and clinically significant abnormal laboratory test results after CAR-γδ T cell infusion (including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)). The planned follow-up duration of this study is 1 years.",[230,295,25],"Lupus Nephritis (LN)","2026-04-09",{"date":298,"type":34},"2026-04-16",{"date":183,"type":21},{"date":301,"type":21},"2028-12-30",{"name":303,"class":41},"Air Force Military Medical University, China",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":193,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":52,"phases":311,"briefSummary":312,"conditions":313,"keywords":314,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":42},"100631939","early-phase-1-allogeneic-cd19bcma-car-t-for-b-cell-related-autoimmune-disease-100631939","NCT07507201","Allogeneic CD19\u002FBCMA CAR-T for B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n* 1)Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n* 2)Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n* 3)Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n* 4)Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n* 5)Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n* 1)Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n* 2)Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n* 3)SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both).\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n* a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n* b) if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n* c) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n* d) Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n* a) Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n* b) \\>50% decline in eGFR within 3 months;\n* c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n* a) Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n* b) Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* c) Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ; or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.",{"count":197,"type":21},[199],"This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219C .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[202,203,204,25,205,206],[208,204,315,316,205,317],"Systemic Lupus Erthematosus","IgAN - IgA Nephropathy","ANCA-Associated Vasculitis (AAV)","2026-03-30",{"date":320,"type":34},"2026-04-02",{"date":322,"type":21},"2026-04-01",{"date":324,"type":21},"2029-12",{"name":218,"class":41},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":333,"sex":17,"minAge":18,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":52,"phases":337,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":4},"100627228","phase-1-a-study-of-rg002c0106-injection-in-adult-participants-with-normal-renal-function-and-mild-to-moderate-renal-impairment-100627228","NCT07445906","A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment","A Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment","Inclusion Criteria:\n\n1. Have been fully informed about the study, volunteered to participate, and provided written informed consent.\n2. Male or female participants aged 18-60 years (inclusive) at screening.\n3. Body mass index (BMI) of 19.0-32.0 kg\u002Fm² (inclusive) at screening; body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants.\n4. Absolute estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI 2021 equation during the screening period, falls into the corresponding group as follows:\n\n   Normal renal function: absolute eGFR ≥ 90 mL\u002Fmin; Mild renal impairment: 60 mL\u002Fmin ≤ absolute eGFR \\\u003C 90 mL\u002Fmin; Moderate renal impairment: 30 mL\u002Fmin ≤ absolute eGFR \\\u003C 60 mL\u002Fmin.\n5. Female participants of childbearing potential must have a negative serum pregnancy test during the screening period. Highly effective contraception must be used from signing the informed consent form until 6 months after the last dose of the study drug, by the participant and their partner of childbearing potential.\n\nExclusion Criteria:\n\n1. At screening, chest radiography demonstrates clinically significant abnormalities.\n2. Any of the following abnormal laboratory test results at screening:\n\n   Total bilirubin \\> 1.5 × upper limit of normal (ULN); ALT or AST \\> 2 × ULN; International normalized ratio (INR) \\> 2 or any clinically significant abnormality; QTcF ≥ 450 ms in males or QTcF ≥ 470 ms in females (QTc interval must be heart rate-corrected using the Fridericia formula); Other abnormal laboratory test results deemed clinically significant by the investigator.\n3. Positive test results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening.\n4. Participants with primary or secondary IgA nephropathy (patients with IgA nephropathy are advised to be screened for the Phase IIa study of the investigational product).\n5. Current diagnosis of tuberculosis (TB); history of active TB with cure \\\u003C 5 years prior to screening; or high likelihood of TB infection as judged by the investigator based on comprehensive TB screening during the screening period.\n6. Presence or suspected presence of other active viral, bacterial, fungal, or parasitic infections within 4 weeks before screening.\n7. History of epidemic meningococcal infection, or other recurrent or chronic infections.\n8. History of splenectomy or asplenia.\n9. History of complement abnormalities or hereditary complement deficiency.\n10. Development of acute kidney injury within 2 weeks before screening.\n11. History of renal transplantation, or requirement for renal dialysis during the study.",true,"60 Years",{"count":336,"type":21},24,[338],"PHASE1","This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous injection of RG002C0106 between trial participants with normal renal function and those with mild to moderate renal impairment.",[341,25],"Renal Impairments","2026-03-01",{"date":344,"type":34},"2026-03-03",{"date":346,"type":21},"2026-03-15",{"date":348,"type":21},"2026-12-01",{"name":350,"class":72},"Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.",{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":52,"phases":359,"briefSummary":360,"conditions":361,"keywords":362,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":370,"locationsCount":42},"100616400","phase-1-car-t-cell-therapy-targeting-cd19-and-bcma-in-patients-with-b-cell-mediated-autoimmune-disease-100616400","NCT07305116","CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease","Inclusion Criteria:\n\n\\- Common Inclusion Criteria:\n\n1\\. Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n\n1. Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n2. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n3. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n4. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%. 2. Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n\n3\\. Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n\nDisease-Specific Inclusion Criteria\n\nSLE:\n\n1. Age ≥ 5 years.\n2. Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n3. Must meet at least one of the following adequate treatment conditions:\n\n   a) Treated with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent) plus one or more immunomodulatory agents (including cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, thalidomide, belimumab, or rituximab) for at least 3 months.\n\n   b) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n\n   c) Patients who cannot taper glucocorticoids to ≤5 mg\u002Fday after 6 months of conventional therapy.\n4. SLE disease activity: SLEDAI-2K score ≥ 8; or SLEDAI ≥ 6 plus at least one BILAG-2004 category A or two category B scores, or both.\n5. No occurrence of macrophage activation syndrome within 1 month prior to screening.\n6. Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n\nMDR-SRNS\n\n1. Age ≥3 years old, gender unlimited.\n2. Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n3. Must meet at least one of the following adequate treatment conditions:\n\n   a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n\n   b) if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n\n   c) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n\n   d) Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n4. Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n\nIgA nephropathy\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. IgA nephropathy pathologically confirmed by renal biopsy;\n3. Angiotensin-Converting Enzyme Inhibitors (ACE) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n   a) Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg; b) \\>50% decline in eGFR within 3 months; c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n4. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n\nRefractory\u002FRelapsed\u002FProgressive Systemic Sclerosis:\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. Scleroderma fulfilling the 2013 ACR classification criteria\n3. Positive scleroderma-related antibodies.\n4. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n5. Must meet at least one of the following adequate treatment conditions:\n\n   1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n   2. Meets criteria for rapidly progressive disease (see Appendix 1) and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n   3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n6. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n\nRefractory\u002FRelapsed ANCA-Associated Vasculitis:\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n3. Has received glucocorticoids (≥1 mg\u002Fkg\u002Fday) in combination with at least one immunosuppressant or biologic agent (including cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, belimumab, telitacicept, etc.) for at least 3 months without achieving sustained remission, or has experienced relapse after remission;or meets the criteria for severe vasculitis (Appendix 1), with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n4. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n5. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n\n  2\\. Subjects with grade III or IV heart failure (NYHA classification). 3. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n\n  4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n\n  5\\. Had active pulmonary tuberculosis at screening. 6. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n\n  7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n\n  8\\. Patients had active central nervous system disease. 9. Patients with malignant diseases such as tumors before screening. 10. Secondary or congenital immunodeficiency. 11. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n\n  12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n\n  13\\. Received live vaccine within 4 weeks before screening. 14. Tested positive in Blood pregnancy test. 15. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n\n  16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n\n  17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome",{"count":197,"type":21},[338],"CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.",[202,203,204,25,205,206],[363,204,315,316,205,317],"CAR-T","2026-01-31",{"date":366,"type":34},"2026-02-03",{"date":368,"type":34},"2025-12-01",{"date":324,"type":21},{"name":218,"class":41},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":151,"enrollmentInfo":377,"targetDuration":4,"studyType":52,"phases":379,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":4},"100620621","the-randomized-controlled-study-of-shenqi-yishen-granules-in-the-treatment-of-iga-nephropathy-100620621","NCT07360002","The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA Nephropathy","Inclusion Criteria:\n\n1. Meets the diagnostic criteria for IgA nephropathy and CKD stages 1-2, 24h-HPro \\> 0.3g;\n2. Meets the diagnostic criteria for \"qi and yin deficiency syndrome\" according to Traditional Chinese Medicine;\n3. Age between 18 and 75 years, gender;\n4. Infection, acidosis, electrolyte imbalance, hypertension, etc., are well controlled;\n5. No failure of other organ functions;\n6. Have good compliance, have not participated in other clinical trials in the past six months; are informed and voluntarily willing to participate in the clinical study.\n\nExclusion Criteria:\n\n* (1) Immediate dialysis treatment is required; currently undergoing treatment with hormones, non-steroidal anti-inflammatory drugs, or immunosuppressive agents; (2) Patients with acute infectious diseases or those under surgical or traumatic stress; (3) Patients with chronic infectious diseases such as active chronic hepatitis B,, decompensated cirrhosis, or active tuberculosis; (4) Patients with severe organ dysfunction affecting survival, such as malignant tumors or HIV infection; (5) Patients with severe primary diseases of the cardiovascular, hematological, neurological, digestive, or respiratory systems, or those with a significant tendency to bleed; (6) Patients with life-threatening conditions such as hyperkalemia or heart failure; (7) Patients with a GFR fluctuation of ≥30% within the past 3 months; (8) Patients with severe allergies to certain known drugs in this study or unable to tolerate them; (9) Patients who are pregnant or breastfeeding; (10) Patients with a history of drug abuse or who have used immunosuppressive agents or glucocorticoids in the past 3 months; (11) Patients with major bleeding or blood transfusion history in the past 3 months, or those with severe clinical infections or signs of acidosis; (12) Patients currently participating in other clinical trials or undergoing other Chinese herbal treatments that may affect efficacy assessment; (13) Patients planning or having undergone kidney transplantation, or those with acute or chronic kidney failure requiring immediate replacement therapy; (14) Patients with post-renal factors, such as obstruction (including stones, uric acid crystals, or tumors) causing acute kidney injury; (15) Patients with a history of mental illness or communication\u002Fcognitive impairments leading to poor compliance and inability to cooperate; (16) Non-Asian individuals.",{"count":378,"type":21},102,[380],"NA","The goal of this clinical trial is to learn if Shenqi Yishen Granules works to treat IgA Nephropathy in adults. It will also learn about the safety of Shenqi Yishen Granules. The main questions it aims to answer are:\n\nDoes Shenqi Yishen Granules lower 24-hour urinary protein quantification of participants? What medical problems do participants have when taking Shenqi Yishen Granules? Researchers will compare Shenqi Yishen Granules to a placebo (a look-alike substance that contains no drug) to see if Shenqi Yishen Granules works to treat IgA Nephropathy.",[25],"2026-01-14",{"date":385,"type":34},"2026-01-22",{"date":387,"type":21},"2026-01",{"date":389,"type":21},"2026-12",{"name":391,"class":41},"Keda Lu",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":151,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":42},"100568038","a-multi-center-open-label-prospective-study-on-early-initiation-of-targeted-release-formulation-of-budesonide-in-patients-with-primary-iga-nephropathy-100568038","NCT06676007","A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy","A Multicenter Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy","Inclusion Criteria:\n\n1. Target patients aged 18-75, including those aged 18 and 75\n2. Primary IgA nephropathy diagnosed by renal biopsy within 3 months\n3. eGFR≥30ml\u002Fmin\u002F1.73m2\n4. 24-hour urine protein ≥ 1.0g\u002Fd, or UPCR ≥ 0.8 g\u002Fg\n5. Sign informed consent\n\nExclusion Criteria:\n\n1. Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis\n2. Patients who have received kidney transplantation or dialysis\n3. Patients with other glomerular diseases (such as C3 glomerular disease and\u002For diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria\\>3.5 g\u002Fd, serum albumin\\\u003C3.0 g\u002Fdl, with or without edema)\n4. Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections\n5. Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c\\>8%)\n6. Patients with a history of unstable angina, grade III or IV congestive heart failure, and\u002For clinically significant arrhythmias\n7. Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg)\n8. Patients diagnosed with malignant tumors within the past 5 years\n9. Patients with known glaucoma, known cataracts, and\u002For a history of cataract surgery\n10. Gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea\n11. Patients with severe adverse reactions to steroids in the past, including psychiatric symptoms\n12. Patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment\n13. Patients who have received any systemic GCS treatment within the past 3 months prior to enrollment\n14. Patients taking potent cytochrome P450 3A4 inhibitors (CYP3A4)\n15. Current or previous (within the past 2 years) alcoholism or drug abuse;\n16. Expected lifespan\\\u003C5 years\n17. During the study treatment period and 3-month follow-up period, women who are pregnant, breastfeeding, or unwilling to use highly effective contraception (contraception is only required for women with fertility potential)\n18. Researchers believe that patients who are not suitable for treatment with Nefecon",{"count":400,"type":21},200,"To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.",[25,403],"Early Initial Therapy",[25,405,406,403],"Nefecon","multi-center","2026-01-13",{"date":409,"type":34},"2026-01-15",{"date":411,"type":34},"2024-10-30",{"date":413,"type":21},"2027-06-30",{"name":415,"class":41},"Sichuan Provincial People's Hospital",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":290,"enrollmentInfo":423,"targetDuration":4,"studyType":52,"phases":424,"briefSummary":425,"conditions":426,"keywords":427,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":434,"locationsCount":42},"100616466","phase-2-a-phase-iia-clinical-study-of-rg002c0106-injection-in-subjects-with-primary-iga-nephropathy-100616466","NCT07305974","A Phase IIa Clinical Study of RG002C0106 Injection in Subjects With Primary IgA Nephropathy","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetic\u002FPharmacodynamic Characteristics of RG002C0106 Injection in Subjects With Primary IgA Nephropathy","Inclusion Criteria:\n\n1. Voluntarily participate in the clinical trial and sign the informed consent form (ICF);\n2. Male or female participants aged 18 to 65 years (inclusive) at the time of signing the ICF;\n3. Body weight ≥ 40 kg;\n4. Negative blood pregnancy test result at screening for female participants of childbearing potential;\n5. Renal biopsy pathology results within 10 years prior to screening confirming a diagnosis of primary IgA nephropathy;\n6. 24-hour urinary protein ≥ 0.75 g\u002F24 h during the screening period;\n7. Estimated glomerular filtration rate (eGFR) (calculated using the creatinine-based CKD-EPI formula) ≥ 30 mL\u002Fmin\u002F1.73 m² during the screening period;\n8. Must have received vaccination against Neisseria meningitidis (serogroups A, C, W, Y) and Streptococcus pneumoniae infections at least 2 weeks prior to the first dose of the investigational product and provide proof of such vaccination;\n9. Participants must agree and require their partners to use adequate contraception from the time of signing the ICF, throughout the study, and for at least 3 months after the study ends . Male participants must not donate sperm for at least 6 months after the last dose of the investigational product.\n\nExclusion Criteria:\n\n1. Patients with secondary IgA nephropathy ;\n2. Renal biopsy pathology shows renal tubular atrophy or interstitial fibrosis ≥ 50%; or crescent formation in ≥ 50% of glomeruli ;\n3. Acute kidney injury or rapidly progressive glomerulonephritis within 4 weeks prior to screening ;\n4. Patients with nephrotic syndrome, defined as: 24-hour urinary protein (24h-UP) \\>3.5 g with hypoalbuminemia (serum albumin \\\u003C3.0 g\u002FdL), hypercholesterolemia (total cholesterol \\>350 mg\u002FdL), and edema;\n5. Any of the following abnormal laboratory results at screening:\n\n   * Alanine aminotransferase (ALT) \\> 2 × upper limit of normal (ULN);\n   * Total bilirubin (TB) \\> 1.5 × ULN. However, for patients with a confirmed diagnosis of Gilbert's syndrome, if TB \\> 1.5 × ULN but conjugated bilirubin \\\u003C ULN, they may be enrolled;\n6. Positive test results at screening for HBsAg, HCV Ab,HIV-IgG, or TP-Ab;\n7. Poorly controlled type 1 or type 2 diabetes during the screening period ;\n8. Persistent clinically significant elevated blood pressure during the screening period ;\n9. Patients with immunodeficiency diseases;\n10. Patients with splenic insufficiency (e.g., asplenia or history of splenectomy);\n11. History of kidney transplantation or organ transplantation (including bone marrow transplantation, stem cell transplantation, etc.);\n12. Suspected or confirmed history of hereditary complement deficiency;\n13. History of any tumor within 5 years before screening, except for the following: basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and squamous cell carcinoma of the skin that have been completely cured after treatment;\n14. History of meningococcal infection within 12 months before screening;\n15. Active or suspected viral, bacterial, fungal, or parasitic infection within 14 days prior to investigational product administration;\n16. History of allergic reactions to oligonucleotides or N-acetylgalactosamine (GalNAc);\n17. History of intolerance to subcutaneous injections or significant abdominal scarring that may impede administration or local tolerance assessment of the investigational product;\n18. Treatment with small-molecule complement inhibitors (e.g., iptacopan) within 3 months prior to investigational product administration, or previous treatment failure or intolerance;\n19. History of clinically significant severe infection within 3 months prior to screening, as determined by the investigator;\n20. Major surgery or severe trauma within 3 months prior to investigational product administration, incomplete recovery, or planned surgery during the study;\n21. Participation in any investigational drug or medical device clinical trial within 1 month prior to investigational product administration (excluding screen failures);\n22. Any other condition considered by the investigator to make the participant unsuitable for inclusion.",{"count":226,"type":21},[54],"This study looks at how well and safely RG002C0106 works for patients with certain kidney disease: primary IgA nephropathy. It's a phase IIa trial done at several locations where both patients and doctors unknow what treatment is being given.",[25],[27],"2025-12-18",{"date":430,"type":34},"2025-12-26",{"date":432,"type":34},"2025-09-08",{"date":164,"type":21},{"name":350,"class":72},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":52,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":122},"100568081","phase-2-avacopan-in-crescentic-immunoglobulin-a-nephropathy-igan-100568081","NCT06676579","Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)","A Multi-Center, Phase II, Open Label, Randomized Trial Evaluating the Efficacy and Safety of Complement 5a Receptor Antagonist Avacopan in Crescentic IgA Nephropathy","Inclusion Criteria\n\n* Age \\> 18 years\n* Kidney biopsy showing crescentic IgA nephropathy within 6 months of enrolment (MEST-C-score =C1\u002FC2).\n* Quantified creatinine clearance \\>20 ml\u002Fmin\u002F1.73m2\n* Quantified Proteinuria \\> 750 mg\u002F24h based on a 24h urine collection while on maximum tolerated dose of RAS blockade\n* Hematuria defined as \\>10 RBC\u002Fhpf or hemoglobinuria \\>1+\n* Patients need to be in adequate supportive care (blood pressure \\\u003C125\u002F85mmHg, lifestyle advice, and maximum doses tolerable of RAS blockade) at least 4 weeks prior to enrollment\n* Patients would receive dietary and lifestyle counseling prior enrollment: low protein (0.8-1.0 g\u002Fkg\u002Fday) diet, low sodium (2 grams\u002Fday) intake, indication for smoke cessation, during the 4 weeks run-in period\n* Has signed an informed consent form prior to any study-related procedures\n* Patients with documented use of RAS blockade and adequate blood pressure control (\\\u003C125\u002F85 mmHg) for ≥4 weeks, can be enrolled in the study and randomized without repeating a 4-week run-in period.\n\nExclusion Criteria\n\n* Creatinine clearance \\\u003C20 ml\u002Fmin\u002F1.73 m2\n* Liver function tests \\> 2x upper limit of normal. (Serious cases of hepatotoxicity have been reported in patients with avacopan during first approval and ADVOCATE study (29) (30)\n* Severe interstitial fibrosis and tubular atrophy (IFTA \\> 70% on renal biopsy)\n* Active cancer or acute non-controlled infection (including HIV, HBV, HCV)\n* Women who are pregnant or breastfeeding\n* Immunosuppression treatment:\n* Rituximab less than 12 months prior to enrollment\n* MMF, CYC, or immunomodulatory agents within 3 months prior to enrollment\n* AZA within 3 months prior to enrollment.\n* Glucocorticoids \\>20 mg\u002Fday within 1 month prior to enrollment\n* Secondary IgA nephropathy (associated with gastrointestinal diseases, infection, autoimmune, malignancy, respiratory tract, or skin)\n* ANCA-associated vasculitis or other vasculitis diagnostic defined by ACR criteria\u002FChapel Hill Consensus conference\n* Contraindication to use any of the protocol treatments (glucocorticoids, avacopan)\n* Use of a strong\u002Fmoderate CYP3A4 inducer\n* Initiation of SGLT2 inhibitors is not allowed once patient has been enrolled in the study. Patients who have been on an SGLT2 inhibitor prior to enrollment on the study may continue on this therapy, at the same dose. No dose increase is allowed.\n* Active, untreated and\u002For uncontrolled chronic liver disease (chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis, cirrhosis\n* Unable to give written consent form\n* As a safety measure patients who are pregnant or lactating will not be enrolled in the study.",{"count":443,"type":21},16,[54],"The purpose of this study is to evaluate the efficacy and safety of Avacopan together with low-dose glucocorticoid in the treatment of patients with crescentic Imunoglobulin A Nephropathy (IgAN) and high risk of progression.",[25],"2025-10-01",{"date":449,"type":34},"2025-10-03",{"date":451,"type":34},"2025-06-09",{"date":453,"type":21},"2029-03-02",{"name":455,"class":41},"Mayo Clinic",{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":333,"sex":17,"minAge":462,"maxAge":18,"enrollmentInfo":463,"targetDuration":4,"studyType":52,"phases":465,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":475,"locationsCount":4},"100597015","phase-3-clinical-study-on-the-efficacy-and-safety-of-telitacicept-in-the-treatment-of-pediatric-iga-nephropathy-or-iga-vasculitis-nephritis-100597015","NCT07052981","Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritis","Inclusion Criteria:\n\n* Diagnosed with IgA nephropathy (IgAN) or IgA vasculitis nephritis (IgAVN) Aged 5 to 18 years Weight ≥25 kg Moderate or heavy proteinuria At enrollment, estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73m² calculated using the Schwartz formula (36.5 × height \\[cm\\] \u002F serum creatinine \\[μmol\u002FL\\]).\n\nWilling to sign the informed consent form\n\nExclusion Criteria:\n\n* There is an ongoing infection that requires antiviral drugs or antibiotics for treatment.\n\nThe patient has received other B cell-targeting biologics within the three months prior to enrollment.\n\nPatients with uncontrolled severe hypertension or diabetes. Individuals with other autoimmune diseases, primary immunodeficiencies, or tumors.\n\nA history of organ transplantation. Patients with chronic active infections, such as Epstein-Barr virus, cytomegalovirus, or Mycobacterium tuberculosis, whose disease state may be exacerbated by the use of steroids and immunosuppressive agents.\n\nPatients with severe liver failure, heart failure, or end-stage renal disease (ESRD).\n\nAny other medical conditions that may place the patient at increased risk by participating in this study.\n\nIndividuals deemed by the investigator as unsuitable for participation in this study.","5 Years",{"count":464,"type":21},124,[133],"This clinical trial is a prospective, multicenter, non-randomized controlled study designed to evaluate the efficacy and safety of Telitacicept, a novel biologic agent, in treating pediatric IgA Nephropathy (IgAN) and IgA Vasculitis Nephritis (IgAVN). The study plans to enroll 124 children aged 5-18, divided into a test group (standard therapy + Telitacicept) and a control group (standard therapy alone), with a 24-week treatment period. The primary endpoint is the change in 24-hour urine protein levels at week 24, while secondary outcomes include UPCR (urine protein-to-creatinine ratio), eGFR, and drug safety.",[25,468],"IgAVN","2025-07-07",{"date":471,"type":34},"2025-07-10",{"date":473,"type":21},"2025-08-01",{"date":413,"type":21},{"name":476,"class":41},"Guixia Ding",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":52,"phases":484,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":42},"100597292","finerenone-in-patients-with-iga-nephropathy-prospective-interventional-trial-100597292","NCT07056595","Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial","Inclusion Criteria:\n\n* Adults (\\> 18 years) with the primary IgAN diagnosed by kidney biopsy;\n* Treatment with stable doses of iRAS or\u002Fand iSGLT2 inhibitors for at least 3 months prior inclusion into the trial;\n* Blood pressure \\\u003C 140\u002F90 mm Hg\n* 24-hour urinary albumin excretion \\> 300 mg\n\nExclusion Criteria:\n\n* Kidney transplantation in medical history\n* Chronic hepatic disease, including hepatitis, malignant tumor, active malignancy;\n* Heart failure with ejection fraction \\\u003C40%;\n* Acute myocardial infarction and\u002For stroke less then 3 months before including in trial;\n* Presence ANCA in serum\n* Ongoing immunosuppressive treatment\n* eGFR \\\u003C 20 ml\u002Fmin\n* Pregnancy and breastfeeding\n* Uncontrolled blood pressure",{"count":226,"type":21},[380],": IgA-nephropathy is the most common glomerulonephritis with the unfavorable prognosis in patients with persistent albuminuria. Finerenone is a new nonsteroidal mineralocorticoid receptor antagonist that has demonstrated efficacy in reducing albuminuria in patients with CKD and type 2 diabetes in two major trials, FIGARO-DKD and FIDELIO. This finding supported the approval of finerenone by the U.S. Food and Drug Administration (FDA) for the treatment of chronic kidney disease (CKD). A subgroup analysis in the pooled FIDELITY trial demonstrated that in patients with CKD stages 1-4 and type 2 diabetes (T2D), the cardio- and nephroprotective effects of finerenone were independent of concomitant therapy with SGLT-2 inhibitors or GLP-1 receptor agonists. Thus, the role of finerenone in slowing CKD progression in T2D can be considered well-established. Given its albuminuria-reducing effects, finerenone is being investigated in multiple trials, including studies on non-diabetic kidney disease and IgA nephropathy, though no published results are available yet. In this trial finerenone will be used as a nephroprotective agent above standard treatment in terms of assessing adverse events and potential efficacy.",[25],"2025-06-30",{"date":489,"type":34},"2025-07-09",{"date":491,"type":34},"2025-05-21",{"date":493,"type":21},"2026-05-21",{"name":495,"class":41},"Botkin Hospital",{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":290,"enrollmentInfo":503,"targetDuration":4,"studyType":52,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":42},"100594678","autoimmune-protocol-diet-intervention-on-proteinuria-in-iga-nephropathy-patients-100594678","NCT07022574","Autoimmune Protocol Diet Intervention on Proteinuria in IgA Nephropathy Patients","Evaluating the Impact of Autoimmune Protocol Diet on Proteinuria in Patients With IgA Nephropathy","Inclusion Criteria:\n\n* Age 18-65\n* Diagnosed with IgA Nephropathy (IgAN)\n* Active disease with urine protein\u002Fcreatinine ratio ≥ 1\n* Stable ARB or ACE inhibitor for at least 1 month prior\n* GFR \\> 30\n* Not on Budesonide 1 month prior or during study\n\nExclusion Criteria:\n\n* Inability to comply with dietary or follow-up requirements\n* Participation in other interventional studies\n* Significant comorbidities interfering with study participation -",{"count":226,"type":21},[380],"This study at UCLA Center for Health Sciences is testing whether the Autoimmune Protocol (AIP) diet can lower protein levels in the urine of people with IgA Nephropathy (IgAN), a common kidney disease that can lead to kidney failure. The AIP diet avoids foods that may cause inflammation (like dairy, grains, and sugar) for 8 weeks, then gradually reintroduces them over 4 months. We're enrolling 30 adults aged 18-65 with IgAN and protein in their urine to try this diet for 6 months. Participants will track their urine protein daily at home, keep a food log, and have monthly lab checkups, with support from a diet expert. The main goal is to see if the diet reduces urine protein by 20% or more, which could slow disease progression and reduce the need for treatments like dialysis. This exploratory study aims to find out if diet changes can help manage IgAN.",[25],[61,508,509,510,511,512,513,514],"Kidney disease","Low inflammation diet","Autoimmune Protocol Diet","Protein in urine","Autoimmune Kidney Disease","Elimination diet","Diet and Kidney disease","2025-06-08",{"date":517,"type":34},"2025-06-15",{"date":519,"type":21},"2026-02-01",{"date":521,"type":21},"2027-12-01",{"name":523,"class":41},"University of California, Los Angeles",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":52,"phases":533,"briefSummary":534,"conditions":535,"keywords":536,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":544,"locationsCount":42},"100579094","phase-3-a-study-of-sc0062-capsule-for-the-treatment-of-iga-nephropathy-with-proteinuria-100579094","NCT06819826","A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SC0062 Capsule in Patients with IgA Nephropathy and Proteinuria (SUCCESS-1)","Inclusion Criteria:\n\n* Voluntarily sign informed consent and fully understand and comply with trial procedures;\n* Age ≥18 years old, gender unlimited;\n* IgA nephropathy patients with proteinuria must meet all of the following conditions:\n\n  1. According to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI, 2009) creatinine equation, after 12 weeks of the stable use of the background therapy, the mean of two estimated glomerular filtration rates (eGFR) calculated from central laboratory results was ≥ 30 and \\\u003C 90 mL\u002Fmin\u002F1.73m2.\n  2. Received the maximum labeled or tolerated dose of RAASi (ACEI or ARB) for at least 12 weeks before randomization; If subjects were treated with SGLT2i, MRA, or GLP-1RA prior to randomization, the stable use was also required for at least 12 weeks (maximum tolerated and optimal dose determined by the investigator; Subjects who are intolerant to RAASi may also be enrolled).\n  3. The pathological examination confirmed IgA nephropathy. Two 24-hour urine samples were collected during the screening period, after 12 weeks of the stable use of the background treatment. Both of the results conducted by the central laboratory were met: 24-hour urine protein to creatinine ratio (UPCR) ≥ 0.75 g\u002Fg or 24-hour urinary protein excretion rate (UPER) ≥ 1.0 g.\n* Laboratory tests shall meet the following criteria:\n\n  1. Serum albumin ≥ 30 g\u002FL;\n  2. Hemoglobin ≥ 90 g\u002FL ; Platelet count ≥80×109\u002FL;\n  3. Brain natriuretic peptide (BNP) ≤ 200 pg\u002FmL or N-terminal pro B-type natriuretic peptide (NT-proBNP) ≤ 600 pg\u002FmL;\n  4. Blood potassium ≤ 5.5 mmol\u002FL;\n  5. Systolic blood pressure (SBP) ≤ 160 mmHg;\n  6. Hemoglobin A1c ≤ 8%;\n  7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2×ULN; Total bilirubin ≤ 1.5×ULN;\n* During the entire study period from the signing of the informed consent to 3 months after the final administration, fertile females and males who have not received vasectomy should take effective contraceptive measures \\[Effective contraceptive measures include: Vasectomy, intrauterine device (IUD), hormones (oral, patch, ring, injection, implant) and barrier methods (diaphragm, cervical cap, sponge, condom).\n\nExclusion Criteria:\n\n* Pregnant or lactating females; Women of childbearing potential (WOCBP) who have a positive blood pregnancy test before randomization;\n* A history of hypersensitivity or allergic to any component of the study drug (SC0062 capsule);\n* Systemic use of corticosteroids or immunosuppressants for more than 2 weeks within 3 months prior to randomization; The following are excluded: local topical or intraarticular, intranasal and inhaled glucocorticoids; Use of biological agents (such as rituximab, Telitacicept, etc.), Iptacopan capsules, budesonide enteric-coated capsules within 6 months prior to randomization;\n* Concurrent diagnosis of chronic kidney disease caused by other etiologies (including polycystic kidney disease, diabetic kidney disease, or other primary glomerular disease) as determined by the investigator;\n* Secondary IgA nephropathy, including but not limited to: Henoch-Schönlein purpura, ankylosing spondylitis, systemic lupus erythematosus, amyloidosis, etc.\n* Renal biopsy results showed that \\> 25% of glomeruli with crescents, or interstitial fibrosis\u002Ftubular atrophy \\> 50%;\n* Based on KDIGO guidelines, rapidly progressive glomerulonephritis was clinically suspected (judged by the investigator);\n* Nephrotic syndrome (UPER \\> 3.5g\u002Fd and serum albumin \\\u003C 30g\u002FL, with or without edema and hyperlipidemia) at screening;\n* A history of any lung disease requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema, pulmonary edema, etc.);\n* Use of the same class drug (endothelin receptor antagonist, ERA) before randomization;\n* A history of moderate or severe edema, non-traumatic facial edema, or myxedema within the 6 months prior to randomization;\n* A history of orthostatic hypotension within 6 months before randomization;\n* A history of clinically significant cirrhosis assessed by the investigator;\n* A history of worsening heart failure, acute coronary syndrome, transient ischemic attack, stroke and other serious cardiovascular and cerebrovascular diseases within 6 months prior to randomization, or NYHA Grade III to IV at screening;\n* A history of kidney or other organ transplantation (except corneal transplantation);\n* A condition which had the potential to interfere with oral drug absorption, such as subtotal gastrectomy, clinically severe gastrointestinal disorders, or certain types of bariatric surgery;\n* Use of potent CYP3A4 inducers and potent CYP3A4 inhibitors within 2 weeks (14 days) before randomization;\n* Received other treatment for IgA nephropathy within 28 days prior to randomization except as permitted by the protocol;\n* Active Hepatitis B, active Hepatitis C, active syphilis and Hiv-positive ;\n* A history of malignant tumors within 5 years, except for skin squamous cell carcinoma, colon polyp or in situ cervical cancer, thyroid papillary carcinoma;\n* A history of alcohol or drug abuse or dependence, or a history of mental illness;\n* Participated in clinical trials of other investigational drugs or medical devices within 3 months prior to randomization;\n* Any other clinically significant disease, condition, or medical history that may interfere with subjects' safety, study evaluation, and\u002For study procedures at the discretion of the investigator;\n* Any other reasons for not being suitable for participating in this clinical study at the discretion of the investigator.",{"count":532,"type":21},360,[133],"This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of SC0062 capsule compared to placebo in patients with IgA nephropathy in the presence of proteinuria. The participants must have a high risk of disease progression, despite of stable use of the maximum tolerated labelled or optimized dose of RAASi and\u002For SGLT2i for at least 12 weeks prior to randomization.",[25],[537],"Endothelin Type A Receptor Antagonist","2025-02-13",{"date":540,"type":34},"2025-02-17",{"date":542,"type":21},"2025-02-14",{"date":185,"type":21},{"name":545,"class":72},"Biocity Biopharmaceutics Co., Ltd.",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":52,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":568},"100576518","phase-2-a-study-of-sgb-9768-in-patients-with-complement-mediated-kidney-diseases-100576518","NCT06786338","A Study of SGB-9768 in Patients with Complement-mediated Kidney Diseases","A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SGB-9768 in Patients with Primary IgA Nephropathy, C3 Glomerulopathy, and Immune Complex-mediated Membranoproliferative Glomerulonephritis.","Inclusion Criteria:\n\n* Aged ≥18 years\n* Weight ≥40 kg, with a body mass index (BMI) between 15 and 35 kg\u002Fm²\n* Biopsy-confirmed diagnosis of primary IgA nephropathy, C3 glomerulopathy or IC-MPGN, accompanied by C3 deposition in the glomeruli.\n* Urine protein-to-creatinine ratio (UPCR) ≥0.75 g\u002Fg\n* Estimated glomerular filtration rate (eGFR) (calculated using the CKD-EPI formula) must be ≥30 mL\u002Fmin\u002F1.73 m².\n* Must be on a stable maximum tolerated doses of ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks\n* Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug\n\nExclusion Criteria:\n\n* Kidney biopsy indicates more than 50% tubular atrophy or interstitial fibrosis.\n* Kidney biopsy shows more than 50% formation of glomerular crescents, or clinical signs suggestive of rapidly progressive glomerulonephritis.\n* IgA nephropathy, C3 glomerulopathy, or IC-MPGN secondary to other diseases\n* Presence of other systemic diseases or kidney diseases that may cause proteinuria\n* Received immunosuppressants or other immunomodulators within 90 days prior to the first administration of the investigational drug\n* Received B-cell targeted biologics or other biologics within 180 days prior to the first administration of the investigational drug\n* Used SGLT2 inhibitors or endothelin receptor antagonists, unless have been stably used for 12 weeks or more\n* Significant comorbidities\n* History of any malignant tumors of any organ system within the past 5 years\n* History of severe trauma or major surgery within 12 weeks prior to screening, or plans to undergo surgery during the study.\n* History of immunodeficiency diseases, congenital asplenia or splenectomy.\n* History of recurrent invasive infections, active systemic bacterial, viral, or fungal infections\n* Positive test results for HBV, HCV, HIV\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \\> 2.5 times the upper limit of normal (ULN)",{"count":554,"type":21},38,[54],"This study looks at how well and safely SGB-9768 works for patients with certain kidney diseases: primary IgA nephropathy, C3 glomerulopathy, and immune complex-related membranoproliferative glomerulonephritis. It's a phase 2 trial done at several locations where both patients and doctors know what treatment is being given.",[25,558,59],"C3 Glomerulopathy","2025-01-20",{"date":561,"type":34},"2025-01-22",{"date":563,"type":21},"2025-04-01",{"date":565,"type":21},"2026-10-01",{"name":567,"class":72},"Suzhou Sanegene Bio Inc.",11,{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":333,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":42},"100574558","raman-spectroscopy-diagnosis-of-kidney-diseases-100574558","NCT06760845","Raman Spectroscopy Diagnosis of Kidney Diseases","Research on Raman Spectroscopy Detection Technology in Kidney Disease Diagnosis","Inclusion Criteria:\n\n1. Age 18 years or older;\n2. Patients diagnosed with IgA nephropathy, idiopathic membranous nephrop, diabetic nephropathy, or focal segmental glomerulosclerosis confirmed by renal biopsy;\n3. Patients who have not received hormone and\u002For immunosup therapy before the renal biopsy;\n\nExclusion Criteria:\n\n1. Presence of factors causing secondary membranous nephropathy: such as autoimmune diseases (systemic lupus erythematosus),\u002Finfections (viral hepatitis), drugs or toxins, etc.;\n2. Severe infection: clinical manifestations such as fever, cough and sputum, throat, abdominal pain, diarrhea, boils and other skin and soft tissue infections, with white blood cell count in blood routine exceeding the normal range (10×09\u002FL);\n3. Severe cardiovascular disease: including chronic heart failure of grade 3 or above and various arrhythmias;\n4. Infect diseases: active phase of various types of hepatitis, AIDS, syphilis, etc.;\n5. Evidence of tumor: already diagnosed with a certain tumor or manifestations, tumor markers, etc. indicating the possibility of a tumor;\n6. Patients with incomplete data or missed diagnosis.",{"count":400,"type":21},"This research plan, from January 2021 to December 2024, aims to collect serum and morning urine from patients diagnosed with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, and focal segmental glomerulosclerosis the Nephrology Department of Qianfoshan Hospital in Shandong Province, through renal biopsy. These samples will be scanned using a Raman spect to obtain Raman spectral data. The scattering peaks in the Raman spectra will be analyzed using Origin software for Gaussian curve fitting. The position of the peaks will used to query relevant literature to identify the corresponding chemical bonds and confirm the presence of compounds.\n\nThe intensity and area of the chemical substance peaks in the Raman will be calculated and used to plot calibration curves, thereby establishing a quantitative analysis equation. This equation will be used to accurately calculate the concentration of each analyte in serum and urine samples. Based on the average concentration data for each patient group, multivariate analysis methods, such as principal component analysis (PCA) and Mahalanis distance discriminant model, will be used to classify and predict the disease types.\n\nThe preliminary data for this study comes from the Nephrology Department ofianfoshan Hospital, where different types of glomerular diseases have been pathologically classified using tools such as light microscopy, electron microscopy, and immunoforescence microscopy. By combining Raman spectroscopy technology and statistical analysis, this study aims to establish a non-invasive and efficient diagnostic tool to assist in the of kidney diseases and predict treatment outcomes.",[25,230,579,157],"Diabetic Nephropathy","2025-01-06",{"date":582,"type":34},"2025-01-07",{"date":584,"type":34},"2021-02-01",{"date":586,"type":21},"2025-07",{"name":588,"class":41},"Zunsong Wang"]