[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"membranous-nephropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:membranous-nephropathy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,49,73,96,133,162,189,212,235,260,286,316,337,359,381,403,505],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100358652","phase-2-belimumab-with-rituximab-for-primary-membranous-nephropathy-100358652",false,"NCT03949855","Belimumab With Rituximab for Primary Membranous Nephropathy","Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI)","REBOOT","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for this study-\n\n1. Age 18 to 75 years inclusive\n2. Diagnosis of one of the following:\n\n   1. Primary MN confirmed by a kidney biopsy within the past 5 years\n   2. Primary MN that is relapsing following a CR (Section 3.3.1) or PR (Section 3.3.2), confirmed by a kidney biopsy within the past 7 years\n   3. Nephrotic syndrome with eGFR \\> 60 mL\u002Fmin\u002F1.73m2 and no history of immunosuppressant treatment (e.g. glucocorticoids, cyclophosphamide, cyclosporine A, tacrolimus, B-cell depleting agent) for nephrotic syndrome, and without evidence of a secondary cause of nephrotic syndrome\n   4. Nephrotic syndrome and a contraindication to kidney biopsy (e.g., anticoagulation, solitary kidney, body habitus that increases the risk of biopsy, or other contraindication in the opinion of the investigator), and without evidence of a secondary cause of nephrotic syndrome\n3. Serum anti-PLA2R positive\n4. eGFR ≥ 30 mL\u002Fmin\u002F1.73m2 while on maximally tolerated RAS blockade\n5. Proteinuria:\n\n   1. ≥ 4 and \\\u003C 8 g\u002Fday that has persisted for at least the previous 3 months while on maximally tolerated RAS blockade. Documentation of persistent proteinuria may be from a 24-hour collection or calculated from a spot urine collection. Or,\n   2. ≥ 8 g\u002Fday while on maximally tolerated RAS blockade\n6. Blood pressure while on maximally tolerated RAS blockade:\n\n   1. Systolic blood pressure ≤ 140 mmHg\n   2. Diastolic blood pressure ≤ 90 mmHg\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will not be eligible for this study-\n\n1. Secondary cause of MN (e.g., SLE, drug, infection, malignancy) suggested by review of the patient's medical history and\u002For clinical presentation\n2. Rituximab use within the previous 12 months\n3. Rituximab use \\> 12 months ago:\n\n   1. With an undetectable CD19 B cell count, or\n   2. Did not result in a CR (Section 3.3.1) or PR (Section 3.3.2) with rituximab treatment alone (e.g., without other immunosuppressive or immunomodulatory therapy)\n4. Use of anti-B cell therapy other than rituximab within the previous 12 months (or 5 half-lives, whichever is greater)\n5. Cyclophosphamide use within the past 3 months\n6. Use of other immunosuppressive medications such as cyclosporine or tacrolimus within the past 30 days\n7. Use of systemic corticosteroids within the past 30 days\n8. Use of any biologic investigational agent (defined as any drug not approved for sale in the country it is used) in the previous 12 months\n9. Use of any non-biologic investigational agent in the past 30 days (or 5 half-lives, whichever is greater)\n10. Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) ≥ 9.0%\n11. Patients with diabetic glomerulopathy on renal biopsy that is:\n\n    1. Greater than Class I diabetic glomerulopathy, or\n    2. Class I diabetic glomerulopathy with a history of poor diabetic control (e.g., HbA1c ≥ 9.0%) since time of biopsy\n12. Unstable kidney function defined as \\> 20% decrease in eGFR during the previous 3 months due to primary MN, as determined by the site investigator in consultation with the protocol chair\n13. Decrease in proteinuria by 50% or more during the previous 12 months\n14. WBC count \\\u003C 3.0 x 103\u002Fμl\n15. Absolute neutrophil count \\\u003C 1.5 x 103\u002Fμl\n16. Moderately severe anemia (hemoglobin \\\u003C 9 g\u002FdL)\n17. History of primary immunodeficiency\n18. Serum IgA \\\u003C 10 mg\u002FdL\n19. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2x the upper limit of normal (ULN)\n20. Positive HIV serology\n21. Positive HCV serology, unless treated with anti-viral therapy with achievement of a sustained virologic response (undetectable viral load 24 weeks after cessation of therapy)\n22. Evidence of current or prior infection with hepatitis B, as indicated by positive HBsAg or positive HBcAb\n23. Positive QuantiFERON - TB Gold test results. PPD tuberculin test may be substituted for QuantiFERON - TB Gold test\n24. History of lung disease with FVC \\\u003C 70% predicted, DLCO \\\u003C 70% predicted, or requiring supplemental oxygen\n25. History of malignant neoplasm within the last 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years\n26. Absence of individualized, age-appropriate cancer screening\n27. Women of child-bearing potential who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception until week 104\n28. Acute or chronic infection, including current use of suppressive therapy for chronic infection, hospitalization for treatment of infection in the past 60 days, or parenteral anti-microbial (including anti-bacterial, anti-viral, or anti-fungal agents) use in the past 60 days for infection\n29. History of an anaphylactic reaction or known sensitivity or intolerance to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies, including rituximab or belimumab\n30. Evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and\u002For any suicidal ideation in the last 2 months, or who in the investigator's judgment, poses a significant suicide risk\n31. Evidence of current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence in the past 12 months\n32. Vaccination with a live vaccine within the past 30 days\n33. Other diseases or conditions or other clinically significant abnormal laboratory value which in the opinion of the investigator would put the patient at risk or confound the results of the study\n34. Inability to comply with study and follow-up procedures","ALL","18 Years","75 Years",{"count":21,"type":22},58,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete or partial remission (CR or PR) compared to rituximab alone in participants with primary membranous nephropathy.\n\nBackground:\n\nPrimary membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in adults. MN affects individuals of all ages and races. The peak incidence of MN is in the fifth decade of life.\n\nPrimary MN is recognized to be an autoimmune disease, a disease where the body's own immune system causes damage to kidneys. This damage can cause the loss of too much protein in the urine.\n\nDrugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by blocking inflammation and reducing the immune system's function. These drugs can have serious side effects and often do not cure the disease. There is a need for new treatments for MN that are better at improving the disease while reducing fewer treatment associated side effects.\n\nIn this study, researchers will evaluate if treatment with a combination of two different drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B cells. B cells are known to have a role in MN. Once these cells are removed, disease may become less active or even inactive. However, after stopping treatment, the body will make new B cells which may cause disease to become active again.\n\nBelimumab works by decreasing the new B cells produced by the body and, may even change the type of new B cells subsequently produced. Belimumab is approved by the US Food and Drug Administration (FDA) to treat systemic lupus erythematosus (also referred to as lupus or SLE). Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis, and vasculitis. Neither rituximab nor belimumab is approved by the FDA to treat MN. Treatment with a combination of belimumab and rituximab has not been studied in individuals with MN, but has been tested in other autoimmune diseases, including lupus nephritis and Sjögren's syndrome.",[28,29],"Membranous Nephropathy","Nephrotic Syndrome",[31,32,33,34,35],"Primary Membranous Nephropathy","nephrotic syndrome","Pharmacokinetics (PK) Analysis","Double-Blind (Masked), Placebo-Controlled Clinical Trial","Co-administered belimumab and rituximab","RECRUITING","2026-06-22",{"date":39,"type":40},"2026-06-24","ACTUAL",{"date":42,"type":40},"2020-03-06",{"date":44,"type":22},"2030-03-01",{"name":46,"class":47},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",20,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100542310","phase-3-personalized-rituximab-treatment-based-on-artificial-intelligence-in-membranous-nephropathy-iritux-100542310","NCT06341205","Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX)","Study of Artificial Intelligence-based Personalized Rituximab Treatment Protocol in Membranous Nephropathy","iRITUX","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ongoing episode of membranous nephropathy diagnosed by the presence of anti-PLA2R1 antibodies detected by ELISA (≥ 14 RU\u002Fml, EUROIMMUN): the result must be validated by the Coordination team before randomization.\n* Nephrotic syndrome defined by proteinuria \\> 3.5 g\u002F24h (or UPCR \\> 3.5 g\u002Fg) and serum albumin \\\u003C 30 g\u002FL at diagnosis\n* Estimated Glomerular Filtration Rate (CKD-EPI formula) \\> 30 mL\u002Fmin\u002F1,73 m2\n* Indication for rituximab treatment according to the KDIGO and French guidelines\n* Non-immunosuppressive antiproteinuric treatment at stable dose for 2 weeks according to French guidelines, including a renin angiotensin aldosterone system inhibitor, a diuretic and a low-salt diet at maximal tolerated dose (i.e., absence of orthostatic hypotension and no increase in creatinine \\> 30%)\n\nExclusion Criteria:\n\n* Secondary Membranous nephropathy related to cancer, infection, systemic lupus, drug\n* Diagnosis of PLA2R1-associated Membranous nephropathy not confirmed by the Coordination team (validation mandatory for randomization)\n* Pregnancy or breastfeeding\n* Immunosuppressive treatment (including rituximab) in the 6 months preceding inclusion\n* Presence of anti-rituximab antibodies detected by Central Lab\n* Cancer under treatment\n* Patients with active, severe infections\n* Hypersensitivity to the active substance or excipients\n* Patients severely immunocompromised\n* Severe heart failure or severe, uncontrolled cardiac disease",{"count":58,"type":22},120,[60],"PHASE3","Membranous nephropathy is an autoimmune disease affecting the kidney, and the most common cause of nephrotic syndrome in non-diabetic Caucasian adults. The course of this disease is highly variable from one individual to another, ranging from spontaneous remission to progressive chronic kidney disease.\n\nThe identification of autoantibodies - e.g., the phospholipase A2 receptor type 1 (PLA2R1) - has promoted the use of immunosuppressive drugs such as rituximab which is now a safe and effective first-line treatment for the management of membranous nephropathy. However, up to 40% of patients do not respond to a first course of rituximab treatment. In nephrotic patients, due to urinary drug loss, rituximab blood level is lower than in other autoimmune diseases treated with rituximab without proteinuria. This high urinary drug loss decreases the drug exposure, potentially explaining why rituximab regimen with low dose infusions (375 mg\u002Fm2) did not demonstrate efficacy after month-6 compared to a non-immunosuppressive antiproteinuric treatment in a previous study. In contrast, a regimen of two 1-g infusions two weeks apart was associated with a significantly greater remission rate after 6 months.\n\nRecently, the investigators have shown that after two 1-g rituximab infusions, the rituximab blood level 3 months after the first rituximab infusion, was correlated with the likelihood of remission after 6 and 12 months of the rituximab treatment. Patients with positive rituximab blood level 3 months after treatment had a higher chance of remission at month-6 and at month-12 than patients with an undetectable rituximab level at month-3.\n\nNowadays, machine learning algorithms are increasingly used in medicine, especially in pharmacology, to predict the exposure to a drug, the initial dose to administer or the interval between two infusions.\n\nThe objective of this study is to use a machine learning algorithm predicting the risk of having an undetectable residual level of rituximab 3 months after treatment, in order to propose a personalized treatment management with early additional doses of rituximab for the patients at risk.",[28],"2026-06-18",{"date":37,"type":40},{"date":66,"type":40},"2025-02-04",{"date":68,"type":22},"2031-09-30",{"name":70,"class":71},"Centre Hospitalier Universitaire de Nice","OTHER",14,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100387552","immunopathological-analysis-in-a-french-national-cohort-of-membranous-nephropathy-100387552","NCT04326218","Immunopathological Analysis in a French National Cohort of Membranous Nephropathy","Immunopathological Analysis in a French National Cohort of Membranous Nephropathy (IHMN)","IHMN","Inclusion Criteria:\n\n* Age 18 years or more\n* Biopsy on a native kidney consistent with MN and\u002For positivity for serum anti-PLA2R1 and\u002For anti-THSD7A antibodies\n* Signed informed consent\n\nExclusion Criteria:\n\n* Diagnosis error based on the kidney biopsy staining or on serology analyses for the positivity for anti-PLA2R1 and\u002For anti-THSD7A\n* Patients unable to give an informed consent\n* Patients withdrawing an informed consent",{"count":82,"type":22},400,[84],"NA","National cohort of all cases of membranous nephropathy (MN) during a 1 year period in France, based on a pathological and\u002For serological diagnostic, collecting the data on:\n\n* incidence of MN\n* prevalence of anti-PLA2R1 and anti-THSD7A\n* clinical outcome one year after diagnosis or after relapse (complete remission, partial remission or persistent nephrotic syndrome)\n* environmental risk factors for the onset of MN\n* HLA markers\n* patient care status in France",[28],"2026-06-15",{"date":89,"type":40},"2026-06-16",{"date":91,"type":40},"2020-07-04",{"date":93,"type":22},"2031-12-03",{"name":70,"class":71},1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":119,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100406380","neptune-match-study-100406380","NCT04571658","NEPTUNE Match Study","Implementing Precision Medicine for Glomerular Diseases in the Nephrotic Syndrome Study Network (NEPTUNE)","NEPTUNE Match","Inclusion Criteria:\n\n1. Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study\n2. Must be potentially eligible for the NEPTUNE Match partnering trials (e.g. if no trial is enrolling a participant under age 6, those under 6 are not eligible).\n\n   Note: NEPTUNE Match partnering trials and associated eligibility criteria are expected to be dynamic and change as trial protocols are developed, activated, and amended.\n3. Regular nephrology healthcare provided at a NEPTUNE study site.\n4. Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match\n\nExclusion Criteria:\n\nCurrently non-NEPTUNE observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments.\n\nExclusion Criteria:\n\n1\\. Non-English or non-Spanish speaking","1 Year","80 Years",{"count":107,"type":22},375,[84],"NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.",[111,112,113,114,28,115,116,117,118],"Nephrotic Syndrome in Children","Focal Segmental Glomerulosclerosis","Minimal Change Disease","Minimal Change Nephrotic Syndrome","FSGS","MCD","MCD - Minimal Change Disease","Alport Syndrome",[29,120,121,122],"NEPTUNE","Match","Clinical Trial Match","2026-06-08",{"date":125,"type":40},"2026-06-10",{"date":127,"type":40},"2022-05-02",{"date":129,"type":22},"2029-12-30",{"name":131,"class":71},"University of Michigan",16,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":120,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":105,"enrollmentInfo":140,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100148840","nephrotic-syndrome-study-network-100148840","NCT01209000","Nephrotic Syndrome Study Network","Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network","Cohort A (biopsy cohort) Inclusion Criteria:\n\nPatients presenting with an incipient clinical diagnosis for FSGS\u002FMCD or MN or pediatric participants not previously biopsied, with a clinical diagnosis for FSGS\u002FMCD or MN meeting the following inclusion criteria:\n\n* Documented urinary protein excretion ≥1500 mg\u002F24 hours or spot protein: creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening\u002Feligibility visit.\n* Scheduled renal biopsy\n\nCohort B (non-biopsy, cNEPTUNE) Inclusion Criteria:\n\n* Age \\\u003C19 years of age\n* Initial presentation with \\\u003C30 days immunosuppression therapy\n* Proteinuria\u002Fnephrotic\n\n  * UA\\>2+ and edema OR\n  * UA\\>2+ and serum albumin \\\u003C3 OR\n  * UPC \\> 2g\u002Fg and serum albumin \\\u003C3\n\nExclusion Criteria (Cohort A\\&B):\n\n* Prior solid organ transplant\n* A clinical diagnosis of glomerulopathy without diagnostic renal biopsy\n* Clinical, serological or histological evidence of systemic lupus erythematosus (SLE) as defined by the ARA criteria. Patients with membranous in combination with SLE will be excluded because this entity is well defined within the International Society of Nephrology\u002FRenal Pathology Society categories of lupus nephritis, and frequently overlaps with other classification categories of SLE nephritis (68)\n* Clinical or histological evidence of other renal diseases (Alport, Nail Patella, Diabetic Nephropathy, IgA-nephritis, monoclonal gammopathy (multiple myelomas), genito-urinary malformations with vesico-urethral reflux or renal dysplasia)\n* Known systemic disease diagnosis at time of enrollment with a life expectancy less than 6 months\n* Unwillingness or inability to give a comprehensive informed consent\n* Unwillingness to comply with study procedures and visit schedule\n* Institutionalized individuals (e.g., prisoners)",{"count":141,"type":22},1200,"OBSERVATIONAL","Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the US of more than $3 billion. However, the clinical classification of these diseases is widely believed to be inadequate by the scientific community. Given the poor understanding of MCD\u002FFSGS and MN biology, it is not surprising that the available therapies are imperfect. The therapies lack a clear biological basis, and as many families have experienced, they are often not beneficial, and in fact may be significantly toxic. Given these observations, it is essential that research be conducted that address these serious obstacles to effectively caring for patients.\n\nIn response to a request for applications by the National Institutes of Health, Office of Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a number of affiliated universities joined together with The NephCure Foundation the NIDDK, the ORDR, and the University of Michigan in collaboration towards the establishment of a Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium.\n\nThrough this consortium the investigators hope to understand the fundamental biology of these rare diseases and aim to bank long-term observational data and corresponding biological specimens for researchers to access and further enrich.",[145,28,146],"Minimal Change Disease (MCD)","Glomerulosclerosis, Focal Segmental",[148,149,112,115,150,116,28,151,29,152,120,153,154],"Focal and Segmental Glomerulosclerosis","Focal & Segmental Glomerulosclerosis","Minimal change disease","MN","Neph Syndrome","NephCure","Halpin",{"date":125,"type":40},{"date":157,"type":40},"2010-04",{"date":159,"type":22},"2030-12-31",{"name":131,"class":71},44,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":95},"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":169,"type":22},30,[171],"EARLY_PHASE1","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.",[174,28,175,176,177],"IgA Nephropathy (IgAN)","ANCA-associated Vasculitis (AAV)\u002FANCA-associated Glomerulonephritis (AAGN)","Refractory Podocytopathy","Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits","NOT_YET_RECRUITING","2026-04-22",{"date":181,"type":40},"2026-04-23",{"date":183,"type":22},"2026-05-30",{"date":185,"type":22},"2028-06-30",{"name":187,"class":188},"Grit Biotechnology","INDUSTRY",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":95},"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":198,"type":22},15,[171],"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.",[28,202,174],"Lupus Nephritis (LN)","2026-04-09",{"date":205,"type":40},"2026-04-16",{"date":207,"type":22},"2026-05-01",{"date":209,"type":22},"2028-12-30",{"name":211,"class":71},"Air Force Military Medical University, China",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100534707","an-outcome-analysis-of-primary-membranous-nephropathy-100534707","NCT06242327","An Outcome Analysis of Primary Membranous Nephropathy","An Observational, Longitudinal Study to Describe the Outcome, and Outcome Predictors, of Patients With Primary Membranous Nephropathy, and the Nephrotic Syndrome Treated With Rituximab, or Other Monoclonal Antibodies","PROMENADE","Inclusion Criteria:\n\n* Adults (≥18 years old) on the day of signing informed consent.\n* Diagnosis of primary membranous nephropathy\n* Nephrotic syndrome (proteinuria \\>3.5 g\u002F24 hours)\n* Written informed consent to the use of recorded data for research purposes.\n\nExclusion Criteria:\n\n* Legal incapacity or limited legal capacity.\n* Any contraindication to treatment with rituximab or other monoclonal antibody",{"count":221,"type":22},500,"This is an observational study intended to track the course of the primary membranous nephropathy disease in real-world clinical practice.\n\nThe study will primarily assess the long-term outcomes of patients with primary membranous nephropathy in the context of advances in treatment options.",[28],[31,29],"2026-03-19",{"date":227,"type":40},"2026-03-23",{"date":229,"type":40},"2024-11-29",{"date":231,"type":22},"2054-06",{"name":233,"class":71},"Mario Negri Institute for Pharmacological Research",2,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":243,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":246,"conditions":247,"keywords":248,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":95},"100369808","autoreactive-b-cells-in-membranous-nephropathy-100369808","NCT04095156","Autoreactive B Cells in Membranous Nephropathy","PLA2R Autoreactive B-Cell Subsets and Immune Cell Monitoring in Membranous Nephropathy: Identification of Outcome Predictors and Novel Insights Into Disease Pathogenesis","PEPTIDE","Inclusion Criteria:\n\nPatients inclusion criteria\n\n* Males and females.\n* Adults (\\> 18 years old).\n* Patients with biopsy-proven idiopathic MN, who are candidate to receive (prospective cohort) or who already received (retrospective cohort) a B-cell depleting treatment as per center clinical practice.\n* Mental state is such that they are able to understand and give valid consent to the study;\n* Written informed consent according to the guidelines of the Declaration of Helsinki.\n\nHealthy volunteers inclusion criteria\n\n* Male and female (\\>18 years) not known to suffer of any significant illness;\n* Not assuming any medication or drug on a regular basis;\n* Negative urine analysis (urine dipstick, multistick);\n* Written informed consent according to the guidelines of the Declaration of Helsinki\n\nExclusion Criteria:\n\nPatients exclusion criteria\n\n* Reasonable possibility of a secondary cause of MN (e.g.systemic lupus erythematosus, active hepatitis B, malignancy, drugs such as gold salts and penicillamine).\n* Legal incapacity, intellectual disability\u002Fmental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent.\n\nHealthy volunteers exclusion criteria\n\n\\- Legal incapacity, intellectual disability\u002Fmental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent.",true,{"count":245,"type":22},86,"Membranous nephropathy (MN) is the most frequent cause of nephrotic syndrome (NS) in adults. The majority of MN patients show detectable circulating antibodies against the M-type phospholipase A2 receptor (PLA2R). Infusion of anti-CD20 monoclonal antibodies results in a profound depletion of B-cells, which are thought to be responsible for anti-PLA2R production. B-cell depletion is followed by NS remission in 70% of cases. Limited evidence highlighted that differences in the B- and T-cell compartments may exist between responders and non-responders. Owing to the non-homogenous efficacy of anti-CD20 treatment, investigators hypothesize that in MN patients who experience NS remission after B-cell depleting therapy, autoreactive B-cells may be mostly circulating, whereas in patients who do not respond to the same treatment, autoreactive B-cells may chiefly reside into secondary lymphoid organs - and thus be more resistant to the drug action. Researchers will therefore extensively analyze the circulating immune repertoire of MN patients before and after the infusion of B-cell lineage depleting agents, assessing the presence of circulating PLA2R autoreactive B cells from appropriately stratified responder and non-responder patients. Patients and healthy controls will be enrolled in this study. Patients will be stratified according to gender, anti-PLA2R status, type of B-cell lineage depleting agent received and response to treatment.",[28],[249,250,251,252],"Membranous nephropathy","B cells","Anti-PLA2R","Anti-CD20 antibodies",{"date":254,"type":40},"2026-03-20",{"date":256,"type":40},"2019-09-25",{"date":258,"type":22},"2026-11",{"name":233,"class":71},{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":243,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":95},"100625000","omics-of-rituximab-resistance-100625000","NCT07416942","Omics of Rituximab-resistance","Identification of a Pharmacogenomic Signature for Anti-B Cell Precision Therapy in Membranous Nephropathy","CONFUCIUS","Patients\n\nInclusion Criteria:\n\n* Adult patients\n* Biopsy-proven primary membranous nephropathy (MN)\n* Written informed consent for storage of biological samples in the local biobank\n\nExclusion Criteria:\n\n* Absence of signed written informed consent for the storage of samples in the biobank\n\nHealthy subjects\n\nInclusion Criteria:\n\n* Adult male and female\n* Written informed consent\n\nExclusion Criteria:\n\n* History of renal diseases, autoimmune disorders, diabetes mellitus, current allergies\n* Subjects who have taken antibiotics, anti-inflammatory drugs, or antihistamines within the past 7 days",{"count":58,"type":22},"The CONFUCIUS project aims to establish a personalised medicine framework for MN patients by integrating pharmacogenomics with other -omics technologies in order to identify biomarkers that predict response to RTX, ultimately enabling optimized treatment selection. Using a multiomics approach, we will analyse genetic variants, serum and kidney proteomics, and serum metabolomics profiles from a well-characterised retrospective cohort of MN patients to uncover predictive biomarkers of RTX response.\n\nThis is a non-pharmacological interventional study, conducted on biological samples from patients stored in the local biobank and on samples from healthy volunteers, which will be collected and subsequently stored in the biobank.",[28],[272,273,250,274,275,276,277],"membranous nephropathy","rituximab","pharmacogenetics","proteomics","metabolomics","scRNAseq","2026-02-10",{"date":280,"type":40},"2026-02-18",{"date":282,"type":22},"2026-04",{"date":284,"type":22},"2029-03",{"name":233,"class":71},{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":294,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":297,"conditions":298,"keywords":305,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":95},"100478094","interview-study-of-adult-and-child-patients-and-parents-of-children-with-swelling-due-to-nephrotic-syndrome-100478094","NCT05505500","Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.","Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome","Prepare-NS","Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:\n\nInclusion Criteria:\n\n1. Parents\u002Fguardians must be able to read and understand English;\n2. Parents\u002Fguardians must be caring for a child (ages 2-11.999) with a medically documented diagnosis of idiopathic (primary) Nephrotic Syndrome (NS) or primary or monogenic NS associated kidney disease. Populations with Primary NS Conditions: Focal segmental glomerulosclerosis (FSGS), Minimal Change Disease (MCD), Immunoglobulin M (IgM) Nephropathy, Membranous Nephropathy (MN), and childhood - onset nephrotic syndrome not biopsied;\n3. The child must have a current NS-associated edema\n4. The child must have native kidney function\n5. Parents\u002Fguardians must provide informed consent.\n\nExclusion Criteria:\n\n1\\. Index case with dialysis dependence throughout the 3-month pre-enrollment period\n\nCriteria for the Patient Reported Outcomes (PRO) cohort of the study:\n\nInclusion Criteria:\n\n1. ≥8 years of age\n2. Able to read and understand English\n3. Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease.\n\n   i. Populations with Primary Nephrotic Syndrome (NS) Conditions include: FSGS, MCD, IgM nephropathy, MN, and childhood - onset nephrotic syndrome not biopsied\n4. Current NS-associated edema\n5. Kidney function with most recent estimated Glomerular Filtration Rate (eGFR) \\> 25 ml\u002Fmin\u002F1.73m2\n6. Informed Consent: For patients ≥8 to \\\u003C18 years of age: a parent or legal guardian provide informed consent and the patient must provide assent. Patients ≥18 years of age must provide informed consent.\n\nExclusion Criteria:\n\n1. Native kidney disease participant with dialysis dependence during the 3-month pre-enrollment period\n2. Co-existing significant chronic or severe acute health condition that has the potential to influence how the participant feels or functions as related to fluid overload in NS","2 Years",{"count":296,"type":22},150,"Researchers from the University of Michigan and Northwestern University are studying people's experiences with swelling caused by Nephrotic Syndrome. Interviews with patients (child and adult) and parents of young children will be conducted. The information collected from the interviews will be used to develop a survey to use when testing new medications for Nephrotic Syndrome.\n\nPlease consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.",[299,146,300,28,113,114,301,29,302,303,111,304,115],"Fluid Overload","Edema","IgM Nephropathy","Glomerular Disease","Nephrotic Syndrome, Minimal Change","Nephrotic Syndrome With Edema (Diagnosis)",[29,306,307,299,300,115,113,28,301],"Child","Adult","2025-12-15",{"date":310,"type":40},"2025-12-22",{"date":312,"type":40},"2022-04-18",{"date":314,"type":22},"2026-04-30",{"name":131,"class":71},{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":5},"100595894","phase-2-a-study-to-evaluate-the-efficacy-safety-and-tolerability-of-human-sialidase-fusion-protein-hlx79-in-combination-with-rituximab-injection-versus-placebo-in-patients-with-active-glomerulonephritis-100595894","NCT07038382","A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis","A Randomized, Controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of HLX79 (Human Sialidase Fusion Protein) in Combination With Rituximab Injection (HLX01, Anti-CD20 Antibody) Versus Placebo in Patients With Active Glomerulonephritis","Inclusion Criteria:\n\n1. Patients who voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the informed consent form (ICF), and are willing to follow and able to complete all study procedures.\n2. Male or female, aged 18-75 years (both inclusive) at the time of signing the ICF.\n3. Diagnosed with primary membranous nephropathy (MN) within 5 year prior to screening\n4. If a diagnosis of primary MN is confirmed, a renal biopsy pathological diagnosis prior to screening or a renal biopsy diagnosis obtained during screening should be available, or patients with nephrotic syndrome and a positive anti-PLA2R antibody test within 6 months prior to screening; secondary MN (secondary to infection, tumor, SLE, drugs, etc.) should be excluded; subjects should have received treatment with angiotensin-converting enzyme inhibitors (ACEIs)\u002Fangiotensin II receptor blocker (ARBs) at the highest tolerated dose judged by the investigator for 3 months prior to screening (unless intolerance to ACEI\u002FARB, contraindications to their use or a low blood pressure that could induce side effects, at the investigator's discretion) and also meet one of the following high-risk criteria:\n\n   * Urine protein \\> 8 g\u002F24 h at screening.(The above 3-month ACEI\u002FARB treatment observation period is not required)\n   * eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2 and urine protein \\> 3.5 g\u002F24 h at screening\n5. Women of childbearing potential (WOCBP) must undergo a pregnancy test at screening and obtain a negative result.\n6. WOCBP or male subjects must agree to take effective contraceptive measures starting from signing the ICF until 12 months after the last dose of the investigational medicinal product (IMP).\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or those with a positive blood pregnancy test prior to randomization.\n2. WOCBP or partners of male subjects who plan to become pregnant during the study.\n3. History of drug or alcohol abuse within 1 year prior to screening.\n4. Malignancy or increased risk of malignancy prior to screening: suspected and\u002For diagnosed with any malignancy (except for basal cell carcinoma, squamous cell carcinoma of skin in situ, or cervical carcinoma in situ occurring within 5 years prior to screening with no evidence of recurrence after treatment).\n5. History of organ transplantation or stem cell or bone marrow transplantation prior to screening, or plan to undergo the above-mentioned transplantations during the study.\n6. Complicated with primary immunodeficiency diseases, type 1 diabetes mellitus, and type 2 diabetes mellitus (Type 2 diabetic patients with a renal biopsy report within one year prior to screening that excludes diabetic nephropathy are eligible to participate in this study) before screening.\n7. Presence of the following diseases that are significantly unstable or poorly controlled at screening: cardiovascular disorder, hematological disease, respiratory disorder, digestive system disorder, endocrine and metabolic system disease, nervous system disorder or psychiatric disorders, skin and subcutaneous tissue disorders, musculoskeletal system disorder, immune system disorders, or Grade 3 or greater medical abnormalities (CTCAE v5.0), and the investigator believes that the subject should be excluded due to the above diseases or abnormalities, or the investigator believes that the above diseases or abnormalities may interfere with the interpretation of the study results.\n8. End-stage renal disease requiring kidney transplantation or dialysis, or oliguria (urine volume \\\u003C 400 mL\u002F24 h) at screening or prior to randomization.\n9. Acute, recurrent, or chronic infection (including but not limited to tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacterial infection) at screening,\n10. Infection requiring intravenous or intramuscular injection of anti-infective drugs within 2 months prior to randomization, or infection requiring hospitalization within 2 months prior to randomization.\n11. Lung CT or chest X-ray at screening suggesting tuberculosis infection or previous tuberculosis infection.\n12. Abnormalities in 12-lead ECG at screening, such as corrected QT (QTc) interval \\> 450 ms in males and corrected QT (QTc) interval \\> 470 ms in females (Fridericia's method).\n13. Abnormal results of the following laboratory tests at screening:\n\n    1. Hemoglobin \\\u003C 90 g\u002FL, or platelet count \\\u003C 100 × 109 L, or neutrophil count \\\u003C 1.5 × 109 L.\n    2. Alkaline phosphatase (ALP) \\> 2 × upper limit of normal (ULN), or total bilirubin (TB) \\> 2 × ULN, or alanine aminotransferase (ALT) \\> 2 × ULN, or aspartate aminotransferase (AST) \\> 2 × ULN, or blood amylase \\> 1.5 × ULN.\n    3. Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2.\n    4. International normalized ratio (INR) \\> 2.5 (not on anticoagulant therapy).\n    5. Interferon gamma release assay positive.\n    6. Serological test positive for human immunodeficiency virus (HIV) antibodies.\n    7. Test results positive for treponema pallidum (syphilis).\n    8. Positive for hepatitis B virus (HBV) surface antigen (HBsAg), or positive for HBV core antibody (HBcAb) and HBV deoxyribonucleic acid (HBV-DNA).\n    9. Hepatitis C virus (HCV) infection (HCV antibody positive with HCV-RNA \\> ULN).\n14. History of serious drug allergy before screening: history of allergy to two or more drugs, or history of allergy or serious side effects to HLX01, HLX79, or their excipients, or history of anaphylaxis to intravascular injection of contrast agents, human or murine proteins, or monoclonal antibodies, or history of anaphylactic shock.\n15. History of or need for treatment with one of the following drugs prior to screening:\n\n    * Treatment with glucocorticoids, MMF (or other forms of mycophenolate) within 1 month prior to randomization\n    * Treatment with calcineurin inhibitors (CNIs) such as tacrolimus and cyclosporine A or other immunosuppressive agents within 3 months prior to randomization\n    * Treatment with alkylating agents such as cyclophosphamide (CYC) and ifosfamide within 6 months prior to randomization\n    * Subjects who still require treatment with glucocorticoids, MMF (or other forms of mycophenolate), or alkylating agents or other immunosuppressive agents during the study as judged by the investigator at screening.\n16. Have received treatment with abatacept, telitacicept, JAK inhibitors, thalidomide, lenalidomide, bortezomib, cladribine, belimumab, rituximab, or other targeted drugs (T lymphocytes, B lymphocytes, interleukin-1, interleukin-6, type I interferon, etc.) within 1 year prior to randomization.Subjects who have received B-cell depleting drugs (such as rituximab) within the past year are eligible to participate in this study if there is evidence that the number of CD19+ or CD20+ B cells have recovered to the lower limit of normal or above.\n17. Have received intravenous infusion of immunoglobulin or plasma exchange within 3 months prior to randomization.\n18. Have participated in a clinical study of other investigational medicinal products prior to screening, with an interval between this study and the previous study being too short: within 1 month prior to the first administration of this study or within 5 half-lives of the previous investigational medicinal product (whichever is longer). Or plan to participate in clinical studies of other investigational medicinal products before completing all scheduled assessments in this clinical study.\n19. Have participated in surgical or device clinical studies within 3 months prior to screening or plan to participate in other surgical or device clinical studies during this clinical study.\n20. Have received any live or live attenuated vaccine within 3 months prior to screening, or plan to receive any live or live attenuated vaccine during the study.\n21. Use of herbal medicines, traditional Chinese medicines, or local traditional remedies that have therapeutic effects for MN within 14 days prior to randomization.\n22. Unable to establish venous access due to poor tolerability or difficulty in finding veins, or unable or unwilling to undergo repeated venipuncture.\n23. Donated whole blood or blood components (more than 400 mL) or lost a large amount of blood (more than 400 mL) within 2 months prior to screening, or plan to donate whole blood or blood components during the study.\n24. The investigator has a clear reason to believe that participation in this study will damage the rights and interests of the subject.",{"count":324,"type":22},24,[25],"The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis.\n\nThe secondary objective are to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HLX79 and HLX01, the clinical efficacy, the dynamic changes of biomarkers of HLX79 in combination with HLX01 in the treatment of glomerulonephritis.\n\nThe subjects will receive different doses of HLX79 (10, 20, or 30 mg\u002Fkg) or placebo, all in combination with HLX01. After the end of the first treatment period, subjects will enter a 20-week follow-up period and then undergo pre-second treatment period assessments. If the investigator determines that the subject does not require the second treatment period, the subject will continue in follow-up until completing the total 48-week follow-up period.",[28,202],"2025-11-14",{"date":330,"type":40},"2025-11-18",{"date":332,"type":40},"2025-08-05",{"date":334,"type":22},"2030-05",{"name":336,"class":188},"Shanghai Henlius Biotech",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":243,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":95},"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":345,"type":22},200,"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.",[174,28,348,349],"Diabetic Nephropathy","Focal Segmental Glomerulosclerosis (FSGS)","2025-01-06",{"date":352,"type":40},"2025-01-07",{"date":354,"type":40},"2021-02-01",{"date":356,"type":22},"2025-07",{"name":358,"class":71},"Zunsong Wang",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":4},"100569139","early-phase-1-im19-car-t-cell-therapy-for-iga-nephropathy-patients-and-membranous-nephropathy-patients-100569139","NCT06690359","IM19 CAR-T Cell Therapy for IgA Nephropathy Patients and Membranous Nephropathy Patients","Evaluation of IM19 CAR-T Cell Therapy for IgA Nephropathy With Urinary Protein and Renal Dysfunction Safety and Efficacy of Patients With Primary Membranous Nephropathy and Those at Medium to High Risk Clinical Research","Inclusion Criteria：\n\n* IgA nephropathy\n\n  1. IgA nephropathy diagnosed through renal biopsy\n  2. When screening, urine protein should be ≥0.5g\u002FgCr and 20mL\u002Fmin\u002F1.73m\\^2≤eGFR\\\u003C60mL\u002Fmin\u002F1.73m\\^2\n  3. Age≥18years old\n  4. Liver, kidney, heart, lung function, and coagulation function meet the following requirements:\n\n     4.1 ALT and AST ≤ 2.5 × ULN,total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert syndrome, ALT and AST ≤ 5 × ULN, total bilirubin ≤ 3 × ULN); 4.2 Left ventricular ejection fraction ≥ 50%; 4.3 International ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 4.4 Finger pulse oxygen saturation\\>92% in non oxygen state;\n  5. Women of childbearing age who have a negative blood pregnancy test before the start of the trial and agree to take effective contraceptive measures during the trial period until the last follow-up; Male participants with reproductive partners agree to take effective contraceptive measures during the trial period until the last follow-up;\n  6. Doctors evaluate patients with the optimal benefit risk ratio\n  7. Those who voluntarily participate in this experiment and sign the informed consent form\n* Primary membranous nephropathy:\n\n  1. Diagnosis of primary membranous nephropathy through renal biopsy;\n  2. Primary membranous nephropathy at medium or high risk that has not improved after 6 months of treatment with CNI and rituximab:\n\n     2.1. Moderate risk assessment criteria 2.1.1. EGFR is normal, 24-hour urine protein is\\>4g, and conservative treatment with angiotensin-converting enzyme inhibitors\u002Fangiotensin receptor blockers has been continuously used for 6 months or more before screening. The 24-hour urine protein has not decreased by less than 50% 2.1.2. PLA2R antibody\\\u003C50RU\u002FmL+ 2.1.3. Low molecular weight urinary protein 2.1.4. Selectivity index\\\u003C0.15 2.1.5. Urinary immunoglobulin UIgG\\\u003C250mg\u002Fday 2.2 High risk assessment criteria 2.2.1. eGFR\\\u003C60ml\u002Fmin\u002F1.73m\\^2 2.2.2. 24-hour urine protein\\>4g and lasting\\>6 months 2.2.3. PLA2R antibody\\>150RU\u002FmL+ 2.2.4. High molecular weight urinary protein 2.2.5. Urine immunoglobulin UigG\\>250mg\u002Fday 2.2.6. Selectivity index\\>0.20\n  3. Age ≥ 18 years old;\n  4. Liver, heart, lung function, and coagulation function meet the following requirements:\n\n     4.1. ALT and AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN (for) Subjects with Gilbert syndrome, ALT and AST ≤ 5 × ULN, total bilirubin ≤ 3 × ULN); 4.2. Left ventricular ejection fraction ≥ 50%; 4.3. International ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 4.4. Finger pulse oxygen saturation\\>92% in non oxygen state\n  5. Women of childbearing age who have a negative blood pregnancy test before the start of the trial and agree to take effective contraceptive measures during the trial period until the last follow-up; Male participants with reproductive partners agree to take effective contraceptive measures during the trial period until the last follow-up\n  6. Doctors evaluate patients with the optimal benefit risk ratio\n  7. Those who voluntarily participate in this experiment and sign the informed consent form\n\nExclusion Criteria:\n\n* IgA nephropathy:\n\n  1. Kidney diseases other than IgA nephropathy, as well as primary and secondary nephrotic syndrome\n  2. After examination by the researchers, it was determined that the subjects had diseases that were not suitable for participation in this study, such as life-threatening conditions (such as catastrophic antiphospholipid syndrome, acute severe renal failure, and acute severe central nervous system disease manifestations)\n  3. Serious complications unrelated to IgA nephropathy\n  4. Use or increase the dosage of corticosteroids, immunosuppressants, biologics (including but not limited to CD20 monoclonal antibodies, taceptil, etc.), anticoagulants (warfarin), and n-3 fatty acids (fish oil) for the drug treatment of IgA nephropathy within 3 months\n  5. Uncontrollable hypertension or hyperglycemia\n  6. Perform palatal tonsillectomy within 6 months\n  7. Study subjects with a history of alcohol or drug abuse within the past 24 weeks\n  8. Have undergone major surgery (including joint surgery) within 24 weeks prior to screening, or plan to undergo surgery within 24 weeks after enrollment in the study\n  9. Used other cell therapies\n  10. Have participated in or participated in other clinical trials within the past 3 months\n  11. Within 3 years or planning to undergo a kidney transplan\n  12. Active hepatitis B or hepatitis C virus, defined as: subjects with positive hepatitis B B virus surface antigen (HBsAg) and\u002For hepatitis B B core antibody (HBcAb, Hepatitis B core antibody) and HBV DNA titer in peripheral blood higher than the lower limit of detection; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA (HCV RNA); Syphilis infected individuals\n  13. Active EB virus and cytomegalovirus, defined as: subjects with positive or negative IgM antibodies in EB virus serum but EBV-DNA higher than normal values; Subjects with IgM antibody positive or IgM antibody negative but CMV-DNA higher than normal in the serum of cytomegalovirus (CMV)\n  14. Serious history of cardiovascular and cerebrovascular diseases, including but not limited to:\n\n      14.1. Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc; 14.2. At rest, QT interval prolongation (QTc\\>450 milliseconds in males or\\>470 milliseconds in females); 14.3. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months prior to the first administration; 14.4. There is heart failure with NYHA functional class ≥ II in the United States;\n  15. History of symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months prior to the start of screening;\n  16. History of malignant tumors other than non melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) (unless in a disease-free state for at least 3 years)\n  17. Infections (fungal, bacterial, viral, or other) that require intravenous injection of antibiotics for control or are uncontrollable, such as simple urinary tract infections and bacterial pharyngitis, may be included if the researcher evaluates that they can be controlled through treatment\n  18. The researchers believe that it does not meet the criteria for joining this clinical trial\n  19. During pregnancy or lactation, it may be due to pregnancy or the male and female not agreeing to undergo contraception under the guidance of the researcher during the study period.\n* Primary membranous nephropathy:\n\n  1. Secondary membranous nephropathy;\n  2. Urinary protein decreased by more than 50% within the first 6 months of screening;\n  3. After examination by the researchers, it was determined that the subjects had diseases that were not suitable for participation in this study, such as life-threatening conditions (such as catastrophic antiphospholipid syndrome, acute severe renal failure, and acute severe central nervous system disease manifestations);\n  4. Serious complications unrelated to primary membranous nephropathy;\n  5. Uncontrollable hypertension or hyperglycemia;\n  6. The study subjects have a history of alcohol or drug abuse within the past 24 weeks;\n  7. Have undergone major surgery (including joint surgery) within 24 weeks prior to screening, or plan to undergo surgery within 24 weeks after enrollment in the study;\n  8. Have used other cell therapies;\n  9. Have participated in or taken part in other clinical trials within the past 3 months;\n  10. Within 3 years or planning to undergo kidney transplantation;\n  11. Active hepatitis B or hepatitis C virus, defined as: subjects with positive hepatitis B B virus surface antigen (HBsAg) and\u002For hepatitis B B core antibody (HBcAb, Hepatitis B core antibody) and HBV DNA titer in peripheral blood higher than the lower limit of detection; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA (HCV RNA); Syphilis infected individuals;\n  12. Active EB virus and cytomegalovirus, defined as: subjects with positive or negative IgM antibodies in EB virus serum but EBV-DNA higher than normal values; Subjects with IgM antibody positive or IgM antibody negative but CMV-DNA higher than normal in the serum of cytomegalovirus (CMV);\n  13. History of serious cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc; At rest, QT interval prolongation (QTc\\>450 milliseconds in males or\\>470 milliseconds in females); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months prior to the first administration; There is heart failure with NYHA functional class ≥ II in the United States;\n  14. History of symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months prior to the start of screening;\n  15. History of malignant tumors other than non melanoma skin cancer or carcinoma in situ (such as cervix, bladder, breast) (unless in a disease-free state for at least 3 years);\n  16. Infections (fungal, bacterial, viral, or other) that require intravenous injection of antibiotics for control or are uncontrollable, such as simple urinary tract infections and bacterial pharyngitis, may be included if the researcher evaluates that they can be controlled through treatment;\n  17. The researcher believes that it does not meet the criteria for joining this clinical trial;\n  18. During pregnancy or lactation, it may be due to pregnancy or the male and female not agreeing to undergo contraception under the guidance of the researcher during the study period.",{"count":367,"type":22},12,[171],"IM19 CAR-T cell therapy for IgA nephropathy patients with urinary protein and renal dysfunction, as well as patients with intermediate to high-risk primary membranous nephropathy",[371,28],"IgA Nephropathy","2024-11-25",{"date":374,"type":40},"2024-11-26",{"date":376,"type":22},"2024-12-13",{"date":378,"type":22},"2026-12-20",{"name":380,"class":188},"Beijing Immunochina Medical Science & Technology Co., Ltd.",{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":388,"targetDuration":390,"studyType":142,"phases":4,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":4},"100540335","circulating-factors-in-nephrotic-syndrome-100540335","NCT06315504","Circulating Factors in Nephrotic Syndrome","Circulating Factors in Nephrotic Syndrome - A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Plasma albumin \\\u003C 36 g\u002FL\n* Urine protein \\>3.5 g\u002Fday or urine protein\u002Fcreatinine-ratio (UPCR) \\> 3.5 or urine albumin\u002Fcreatinine-ratio (UACR) \\>2200 mg\u002Fg\n* Planned kidney biopsy\n* Able to give written informed consent\n\nExclusion Criteria:\n\n* Kidney transplant recipient\n* Previously undergone a kidney biopsy\n* Unable to understand written information in Danish",{"count":389,"type":22},104,"10 Years","A prospective observational study to investigate the treatment-associated changes of circulating factors associated with glomerular diseases among patients with de novo nephrotic syndrome admitted to hospital for a kidney biopsy.",[29,28,113,393],"Primary Focal Segmental Glomerulosclerosis","2024-03-16",{"date":396,"type":40},"2024-03-19",{"date":398,"type":22},"2024-04-01",{"date":400,"type":22},"2034-04-01",{"name":402,"class":71},"Iain Bressendorff",{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":411,"targetDuration":413,"studyType":142,"phases":4,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":95},"100521150","national-registry-of-rare-kidney-diseases-100521150","NCT06065852","National Registry of Rare Kidney Diseases","National Registry of Rare Kidney Diseases (RaDaR)","RaDaR","* Kidney Rare Disease\n* Paeds and adults\n* Eligibility differs for each rare disease group\n* See: https:\u002F\u002Fukkidney.org\u002Frare-renal\u002Frecruitment",{"count":412,"type":22},35000,"30 Years","The goal of this National Registry is to is to collect information from patients with rare kidney diseases, so that it that can be used for research.\n\nThe purpose of this research is to:\n\n* Develop Clinical Guidelines for specific rare kidney diseases. These are written recommendations on how to diagnose and treat a medical condition.\n* Audit treatments and outcomes. An audit makes checks to see if what should be done is being done and asks if it could be done better.\n* Further the development of future treatments.\n\nParticipants will be invited to participate on clinical trials and other studies. The registry has the capacity to feedback relevant information to patients and in conjunction with Patient Knows Best (Home - Patients Know Best), allows patients to provide information themselves, including their own reported quality of life and outcome measures.",[416,417,418,419,118,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,112,453,454,455,456,457,458,459,371,460,461,462,463,464,465,466,467,468,469,28,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487,488,489,490,491,492,493,494,495],"Adenine Phosphoribosyltransferase Deficiency","AH Amyloidosis","AHL Amyloidosis","AL Amyloidosis","Atypical Hemolytic Uremic Syndrome","Autoimmune Distal Renal Tubular Acidosis","Autosomal Recessive Proximal Renal Tubular Acidosis","Autosomal Recessive Distal Renal Tubular Acidosis","Autosomal Dominant Polycystic Kidney Disease","Autosomal Recessive Polycystic Kidney Disease","Bartter Syndrome","BK Nephropathy","C3 Glomerulopathy With Monoclonal Gammopathy","C3 Glomerulopathy","Calciphylaxis","Crystalglobulinaemia","Crystal-storing Histiocytosis","Cystinosis","Cystinuria","Dense Deposit Disease","Dent Disease","Denys-Drash Syndrome","Dominant Hypophosphataemia With Nephrolithiasis and\u002For Osteoporosis","Drug Induced Fanconi Syndrome","Drug-Induced Hypomagnesemia","Drug-Induced Nephrogenic Diabetes Insipidus","Epilepsy, Ataxia, Sensorineural Deafness and Tubulopathy","Fabry Disease","Familial Hypomagnesemia With Hypercalciuria and Nephrocalcinosis","Familial Primary Hypomagnesemia With Hypocalcuria","Familial Primary Hypomagnesaemia With Normocalciuria","Familial Renal Glucosuria","Fanconi Renotubular Syndrome 1","Fanconi Renotubular Syndrome 2","Fanconi Renotubular Syndrome 3","Fibrillary Glomerulonephritis","Fibromuscular Dysplasia","Generalised Pseudohypoaldosteronism Type 1","Gitelman Syndrome","Heavy-Metal-Induced Fanconi Syndrome","Hepatocyte Nuclear Factor 1-Beta-Associated Monogenic Diabetes","Hereditary Renal Hypouricemia","Hereditary Hypophosphatemic Rickets With Hypercalciuria","Hyperuricaemic Nephropathy","Immunotactoid Glomerulonephritis With Organised Microtubular Mononoclonal Immunoglobulin Deposits","Inherited Renal Cancer Syndromes","Intracapillary Monoclonal IgM Without Cryoglobulin","Intraglomerular\u002FCapillary Lymphoma\u002FLeukaemia","Isolated Autosomal Dominant Hypomagnesaemia Glaudemans Type","Liddle Syndrome","Light Chain Cast Nephropathy","Light Chain Proximal Tubulopathy Without Crystals","Light Chain Proximal Tubulopathy With Crystals","Lowe Syndrome","Membranoproliferative Glomerulonephritis","Medullary Cystic Kidney Disease","Minimal Change Nephropathy","Mitochondrial Disease Of The Kidney","Monoclonal Immunoglobulin Deposition Disease","Nail Patella Syndrome","Nephrogenic Diabetes Insipidus","Nephrogenic Syndrome of Inappropriate Antidiuresis","Nephronophthisis","Primary Hypomagnesemia With Secondary Hypocalcemia","Primary Hyperoxaluria","Proliferative Glomerulonephritis With Monoclonal IgG Deposits","Proximal Tubulopathy Without Crystals","Pseudohypoaldosteronism Type 1, 2A-2E","Pure Red Cell Aplasia","Retroperitoneal Fibrosis","Sickle Cell Nephropathy","Shiga Toxin Associated Haemolytic Uraemic Syndrome","Steroid Resistant Nephrotic Syndrome","Steroid-Sensitive Nephrotic Syndrome","Thin Basement Membrane Nephropathy","Thrombotic Microangiopathy With Monoclonal Gammopathy","Type 1 Cryoglobulinaemic Glomerulonephritis","Tuberous Sclerosis","Unclassified Monoclonal Gammopathy Of Renal Significance","Vasculitis","2023-09-26",{"date":498,"type":40},"2023-10-04",{"date":500,"type":40},"2009-11-06",{"date":502,"type":22},"2039-12-31",{"name":504,"class":71},"UK Kidney Association",{"id":506,"slug":507,"hasResults":11,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":513,"targetDuration":515,"studyType":142,"phases":4,"briefSummary":516,"conditions":517,"keywords":520,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":535},"100357120","korea-renal-biobank-network-system-toward-next-generation-analysis-100357120","NCT03929887","KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis","Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research","KORNERSTONE","1. Inclusion criteria\n\n   * Patient suspected of glomerular disease who received kidney biopsy in participating university medical centers\n   * Children (age\\\u003C18 years) also included\n2. Exclusion criteria - Patients who previously received a kidney transplant",{"count":514,"type":22},3000,"20 Years","Glomerulonephritis (GN) generates an enormous individual and social economic burden. However, the therapeutic options are largely based on clinical and pathological parameters and the individual response to therapy or prognosis is uncertain.\n\nRecently, along with advances in molecular analysis and computational bioinformatics, genomic data from human renal biopsies could provide a strong foundation for the future of precision medicine in nephrology.\n\nIn response to a request for applications by the Ministry of Health and Welfare of Korea for the creation of Clinical Research Registry, multi-center N network has been established for prospective cohort with kidney biopsy samples (KORNERSTONE).\n\nThrough this Network the investigators hope to understand the fundamental biology of glomerulonephritis and aim to bank long-term observational data and corresponding biological data including genomic data from kidney tissues, and kidney pathologic data which is digitalized This database is archived to a web-based platform to access easily and further enrich for researchers.",[302,113,371,28,112,518,519],"Lupus Nephritis","Crescentic Glomerulonephritis",[521,522,523,524,525],"Glomerular disease","sample repository","clinical data","digital pathology repository","web-based database","2020-02-10",{"date":528,"type":40},"2020-02-12",{"date":530,"type":40},"2019-05-01",{"date":532,"type":22},"2028-12-31",{"name":534,"class":71},"Seoul National University Hospital",6]