[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-iga-nephropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-iga-nephropathy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,64,89,109,129,159],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100500542","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-sefaxersen-ro7434656-in-participants-with-primary-immunoglobulin-a-iga-nephropathy-at-high-risk-of-progression-100500542",false,"NCT05797610","A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression","A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sefaxersen, an Antisense Inhibitor of Complement Factor B, in Patients With Primary IgA Nephropathy at High Risk of Progression","IMAGINATION","Inclusion Criteria:\n\n* Primary IgAN, as evidenced by a kidney biopsy performed within 10 years prior to or during screening, without known secondary cause\n* Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) for at least 90 days immediately prior to screening, and without an intent to modify the dose during the study, except for interruptions due to illness (not greater than 7 consecutive days), unless the potential participant is intolerant to these medications\n* Urine Protein-to-Creatinine Ratio (UPCR) ≥ 1 gram per gram (g\u002Fg) or urine protein excretion ≥ 1 gram per day (g\u002Fday) (with UPCR ≥ 0.8 g\u002Fg), all measured from a 24-hour urine collection during screening\n* eGFR ≥ 20 mL\u002Fmin\u002F1.73 m\\^2, as calculated by the 2021 CKD-EPI creatinine equation (Inker et al. 2021a)\n* Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to national vaccination recommendations\n* Female participants of childbearing potential must use adequate contraception\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of sefaxersen\n* Histopathologic or other evidence of another autoimmune glomerular disease\n* Presence of ≥ 50% crescents on kidney biopsy, sustained doubling of serum creatinine within 3 months prior to screening, or rapidly progressive glomerulonephritis in the opinion of the investigator\n* History of kidney transplantation\n* Glycated Hemoglobin (HbA1c) ≥ 6.5% or a clinical diagnosis of diabetes mellitus of any type\n* Systolic blood pressure \\>140 millimetre of mercury (mmHg) or diastolic blood pressure \\>90 mmHg from the average of two measurements performed at least 1 minute apart during screening\n* Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitors within 16 weeks prior to screening or during screening\n* Initiation of endothelin receptor antagonists within 90 days prior to screening or during screening\n* Initiation of mineralocorticoid receptor antagonists or non-dihydropyridine calcium channel blockers within 90 days prior to screening or during screening\n* Use of herbal therapies within 90 days prior to or during screening\n* Treatment with investigational therapy within 28 days prior to screening or 5.5 drug-elimination half-lives of that investigational product prior to screening\n* Treatment with an investigational therapy planned during the treatment period\n* Previous treatment with sefaxersen\n* Treatment with oral or intravenous (IV) corticosteroids with a dose equivalent to ≥ 7.5 milligrams per day (mg\u002Fday) of prednisone for 7 days or equivalent to ≥ 5 mg\u002Fday of prednisone for 14 days within 90 days prior to screening\n* Treatment with corticosteroids with systemic effects during screening\n* Treatment with a systemic calcineurin inhibitor within 2 months prior to screening or during screening\n* Treatment with anti-CD20 therapy within 9 months of screening or during screening\n* Treatment with other systemic immunosuppressive agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), azathioprine, or mycophenolate\n* Planned major procedure or major surgery during screening or the study\n* Substance abuse within 12 months prior to screening or during screening\n* Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study\n* History of malignancy within \\\u003C 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death\n* Usage of Glucagon-like Peptide-1 (GLP-1)-based therapy (i.e., GLP-1 mono-agonists, GLP-1\u002FGIP dual agonists, etc.) within 90 days prior to screening or during screening, or intent to initiate during the study period","ALL","18 Years",{"count":20,"type":21},428,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of sefaxersen (RO7434656), a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.",[27],"Primary IgA Nephropathy","RECRUITING","2026-06-11",{"date":31,"type":32},"2026-06-15","ACTUAL",{"date":34,"type":32},"2023-08-08",{"date":36,"type":21},"2029-03-31",{"name":38,"class":39},"Hoffmann-La Roche","INDUSTRY",204,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":63},"100620231","phase-2-a-study-of-shr-2173-in-participants-with-primary-iga-nephropathy-100620231","NCT07354932","A Study of SHR-2173 in Participants With Primary IgA Nephropathy","A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Primary IgA Nephropathy","Inclusion Criteria:\n\n1. Male and female participants aged 18 or older\n2. Body weight ≥35 kg, BMI\\\u003C37.5 kg\u002Fm2\n3. At screening, 24-hour urinary protein quantification ≥1 g\u002F day, or 24-hour UPCR≥0.7 g\u002Fg\n4. eGFR≥30 mL\u002F minute \u002F1.73 m2 at screening\n5. Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm\u002Feggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol\n\nExclusion Criteria:\n\n\\-\n\n1、Presence of any of the following medical histories or comorbidities:\n\n1. Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary to systemic diseases, infections, autoimmune diseases or tumors;\n2. A history of organ transplantation;\n3. A history of splenectomy;\n4. Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ with complete resection and no evidence of recurrence are excluded);\n5. A history of anaphylaxis such as generalized urticaria, angioedema, or anaphylaxis, or a known history of allergy to the study drug or any component of the study drug\n\n2、Use of any of the following drugs\u002Ftreatments or participation in a clinical study:\n\n1. Received systemic glucocorticoid therapy (including gut-targeted budesonide, etc.) within 12 weeks before randomization (Note: except those not used within 4 weeks before randomization and received prednisone ≤0.5mg\u002Fkg or equivalent glucocorticoid for non-IgAN disease within 52 weeks before randomization, with no more than 3 courses (each course ≤2 weeks);\n2. Receivied immunosuppressive therapy within 12 weeks before randomization;\n3. Received any investigational drug within 4 weeks before randomization or within the 5 half-lives of the trial drug, whichever was longer;\n4. Received a live \u002F attenuated live vaccine administered within 4 weeks before randomization\n\n3、History and examination related to infection:\n\n1. A history of infection (viral, bacterial, fungal, parasitic infection) within 3 months prior to screening, resulting in hospitalization and\u002For parenteral systemic antimicrobial therapy; Or a history of infection requiring systemic antimicrobial therapy within 14 days before randomization;\n2. Tuberculosis (TB) or occult TB infection (one of the following conditions) :\n\n   1. Presence of active TB or clinical symptoms of active TB at screening;\n   2. Signs of active TB on imaging examination within 3 months before screening\n\n      4、 General situation:\n\n1\\) Pregnant or lactating women; 2) Investigators determine that there are circumstances that affect the safety and efficacy evaluation of the investigational drug, or other circumstances not appropriate for participation in this study.",{"count":49,"type":21},84,[51],"PHASE2","This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with Primary IgA Nephropathy(IgAN). The study consists of a screening period, a run-in period, a 48-week double-blind treatment period, and a 12-week follow-up period. Approximately 84 IgAN patients will be included.",[27],"2026-05-11",{"date":56,"type":32},"2026-05-13",{"date":58,"type":32},"2026-03-09",{"date":60,"type":21},"2027-12",{"name":62,"class":39},"Guangdong Hengrui Pharmaceutical Co., Ltd",2,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100631284","early-phase-1-a-study-of-ykst02-in-participants-with-primary-iga-nephropathy-100631284","NCT07498673","A Study of YKST02 in Participants With Primary IgA Nephropathy","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YKST02 in Participants With Primary IgA Nephropathy","Inclusion Criteria:\n\n* Diagnosis of primary IgA nephropathy (IgAN)\n* Proteinuria above a protocol-defined threshold at screening\n* Receiving stable standard-of-care therapy for IgAN for an adequate duration prior to enrollment, unless contraindicated or not tolerated\n* Women of childbearing potential must have a negative pregnancy test prior to study drug administration and agree to use effective contraception; male participants must agree to use effective contraception\n* Able to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Secondary IgA nephropathy (e.g., associated with liver disease, autoimmune disorders, infections, or other systemic conditions)\n* Other clinically significant renal diseases unrelated to IgAN (e.g., diabetic nephropathy, lupus nephritis, vasculitis)\n* Nephrotic syndrome considered unsuitable for study participation\n* Rapidly progressive glomerulonephritis or rapidly declining renal function\n* Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m²\n* Immunodeficiency or low immunoglobulin G (IgG) levels below normal\n* Clinically significant abnormal laboratory findings (e.g., hematologic, hepatic, or coagulation abnormalities)\n* Requirement for systemic corticosteroids for concomitant conditions\n* Use of immunosuppressive, targeted, or biologic therapies within a defined period prior to screening or anticipated use during the study\n* Prior treatment with B-cell-depleting or other targeted biologic therapies within a defined period\n* History of demyelinating disorders (e.g., multiple sclerosis)\n* Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening\n* History of organ transplantation or planned transplantation during the study\n* Current dialysis or anticipated need for dialysis during the study\n* Major surgery within 4 weeks prior to screening or planned during the study\n* Active infection requiring systemic therapy, recent serious infection, or chronic\u002Frecurrent infections\n* Known active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection\n* Active or untreated latent tuberculosis\n* History of splenectomy\n* Uncontrolled comorbidities (e.g., poorly controlled hypertension or diabetes)\n* Malignancy within the past 5 years, except adequately treated non-invasive cancers\n* Known hypersensitivity to YKST02 or its components\n* Receipt of another investigational product within 4 weeks or 5 half-lives (whichever is longer) prior to screening\n* Receipt of live or attenuated vaccines within 4 weeks prior to screening or planned during the study\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for the study","75 Years",{"count":73,"type":21},12,[75],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the safety and tolerability of YKST02 and to explore its potential to treat adults with primary IgA nephropathy (IgAN). The study will also assess how the drug moves through the body and how it affects the immune system.\n\nThe main questions it aims to answer are:\n\n* Is YKST02 safe and well tolerated?\n* Does YKST02 reduce protein levels in the urine?\n* How does YKST02 behave in the body (pharmacokinetics, PK)?\n* How does YKST02 affect the immune system (pharmacodynamics, PD)? Participants are adults with IgAN who have persistent proteinuria despite standard treatment.\n\nParticipants will:\n\n* Receive YKST02 by intravenous (IV) infusion\n* Be monitored after each dose for safety\n* Attend clinic visits for safety assessments and laboratory tests\n* Provide blood and urine samples during the study and follow-up period",[27],"2026-05-07",{"date":80,"type":32},"2026-05-12",{"date":82,"type":32},"2026-05-06",{"date":84,"type":21},"2027-06-30",{"name":86,"class":87},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":88},"100638372","phase-2-a-trial-to-evaluate-the-long-term-safety-and-tolerability-of-hrs-5965-in-patients-with-primary-iga-nephropathy-100638372","NCT07582133","A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA Nephropathy","A Multicenter, Open-label Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 Capsules in Patients With Primary IgA Nephropathy","Inclusion Criteria:\n\n1. Patients with primary IgA nephropathy who completed treatment in Study HRS-5965-305, or who prematurely discontinued study drug during the maintenance phase following initiation of rescue therapy;\n2. Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.\n\nExclusion Criteria:\n\n1. Hypersensitivity to the study drug or its components；\n2. History of immunodeficiency disorders；\n3. History of invasive encapsulated bacterial infection；\n4. History of malignant neoplasm；\n5. The estimated glomerular filtration rate (eGFR) is less than 20 mL\u002Fmin\u002F1.73m2；",{"count":97,"type":21},380,[51],"This study aims to evaluate the long-term safety of HRS-5965 capsules in patients with primary IgA nephropathy, and also to assess its efficacy in reducing 24-hour urinary protein and delaying the decline in eGFR in these patients.",[27],"NOT_YET_RECRUITING",{"date":80,"type":32},{"date":104,"type":21},"2026-05",{"date":106,"type":21},"2029-11",{"name":108,"class":39},"Chengdu Suncadia Medicine Co., Ltd.",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":88},"100594083","phase-3-a-trial-of-hrs-5965-capsule-in-primary-iga-nephropathy-100594083","NCT07014826","A Trial of HRS-5965 Capsule in Primary IgA Nephropathy","Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of HRS-5965 Capsule in Primary IgA Nephropathy","Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent；\n2. Weight ≥35 kg, Body mass index (BMI) \\\u003C 37.5kg \u002Fm2;\n3. Primary IgA nephropathy was confirmed by renal biopsy within 8 years;\n4. 24-UPE≥ 1.0g \u002F24h, or 24-UPCR≥ 0.8g\u002Fg at screen, and 24-UPCR≥ 0.8g\u002Fg prior to randomization;\n5. eGFR≥30 ml\u002Fmin\u002F1.73m2 at screening and prior to randomization; (CKD-EPI formula)\n6. A fertile female subject or a male subject whose partner is a fertile female, who has not had a fertility, sperm\u002Fegg donation plan from the signing of the informed consent to 1 month after the last dose, and voluntarily takes effective contraceptive measures (including the partner);\n7. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.\n8. Receiving optimal supportive therapy including RAS blockers and stabilizing the dose for at least 12 weeks after reaching the maximum recommended dose or the maximum tolerated dose prior to randomization;\n\nExclusion Criteria:\n\n1. Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;\n2. Patients with secondary IgA nephropathy as determined by the investigator;\n3. IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;\n4. Patients with a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria; Or with Nephrotic Syndrome;\n5. Have any organ transplant;\n6. Patients with active infection of tuberculosis within 1 year prior to screening, such as liver abscess and pyelonephritis; Or subjects with active infection who requiring intravenous antibiotic therapy within 2 weeks prior to randomization;\n7. Patients with a history of malignant neoplasms;\n8. Patients with a history of severe trauma or major surgery within 12 weeks prior to screening, or who plan to undergo surgery during the study period;\n9. Patients with a history of blood donation or a history of severe blood loss (≥400 mL blood loss) within 12 weeks prior to screening, or who have received blood transfusions within 12 weeks prior to screening;\n10. The presence of a disease or medical condition determined by the investigator might affect drug absorption, distribution, metabolism, and excretion;\n11. As determined by the investigator, the subject has any of the following: progression or recovery of a disease;\n12. Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or total bilirubin exceeding 3 times the upper limit of normal (ULN) at screening;\n13. Participants who have participated in a clinical trial of any drug or medical device within 12 weeks prior to randomization and are expected to have residual effects of the investigational treatment (as determined by the investigator), or who were within the follow-up period of a clinical study, or within 5 half-lives of the investigational drug, or within 30 days (whichever is older) before screening;\n14. Women who are pregnant or breastfeeding;\n15. A history of drug abuse;\n16. Participants who received systemic glucocorticoid or immune suppressants within 12 weeks prior to randomization and are expected to have during research；\n17. Participants who received biologics or cytokine inhibitor within 6 months prior to randomization and are expected to have during research；\n18. Any physical or mental illness or condition that, as determined by the investigator, is likely to increase the risk of the study, affect the subject's adherence to the protocol, or prevent the subject from completing the study.",{"count":117,"type":21},378,[24],"This multicenter, randomized, double-blind, parallel, placebo-controlled study is being conducted to evaluate the efficacy, and safety of HRS-5965 capsule for primary IgA nephropathy.",[27],"2025-07-31",{"date":123,"type":32},"2025-08-05",{"date":125,"type":32},"2025-06-04",{"date":127,"type":21},"2028-12",{"name":108,"class":39},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":71,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":145,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":63},"100598704","tonsillectomy-and-immunosuppression-in-caucasian-patients-with-high-risk-iga-nephropathy-100598704","NCT07074951","Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy","Effectiveness of Immunosuppression Combined With Tonsillectomy in Caucasian Patients With High-risk IgA-nephropathy (the Pragmatic Study)","Inclusion Criteria:\n\nPrimary IgA-nephropathy (IgAN) patients with:\n\n1. DP \\>1 g with haematuria (\\>5 RBC\u002FHPF)\n2. DP \\\u003C1 g with haematuria AND probability of starting dialysis within 5 years \\>11% (estimated by the International risk-prediction tool in IgAN) AND at least one of the following histologic changes: at least one of the following histologic changes: mesangial proliferation, endocapillary hypercellularity, cellular crescents\n\nExclusion Criteria:\n\n1. Age \\\u003C18 or \\>75 years;\n2. eGFR ≤20 ml\u002Fmin\u002F1.73m2\n3. Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP \\\u003C1.0 g\n4. Contraindications to IST or TE\n5. Patients with any co-existing kidney disease\n6. Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)\n7. Patients with diabetes mellitus\n8. Any clinically significant acute illness within 60 days prior to kidney biopsy (including infection, aseptic necrosis of any bone, patients with myocardial infarction or cerebrovascular stroke, other conditions that can be exacerbated by corticosteroids\n9. Incomplete empiric IST administered prior to kidney biopsy\n10. Pregnancy",{"count":137,"type":21},240,[139],"NA","The open-label prospective non-randomised controlled aims to assess the efficacy of the combination of immunosupression (IST) and tonsillectomy (TE) in Caucasian patients at high risk of the IgA-nephropathy.",[142,143,144],"Primary IgA-nephropathy","High-risk","Caucasians",[142,146,147,143,144,148,149],"Corticosteroids","Tonsillectomy","Progression","Remission","2025-07-10",{"date":152,"type":32},"2025-07-20",{"date":154,"type":32},"2013-03-10",{"date":156,"type":21},"2027-12-10",{"name":158,"class":87},"St. Petersburg State Pavlov Medical University",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100591562","phase-2-evaluate-the-efficacy-and-safety-of-ntq5082-capsules-in-patients-with-primary-iga-nephropathy-100591562","NCT06982040","Evaluate the Efficacy and Safety of NTQ5082 Capsules in Patients With Primary IgA Nephropathy","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of NTQ5082 Capsules in the Treatment of Patients With Primary IgA Nephropathy","Inclusion Criteria:\n\n1. Age ≥18 years, male or female.\n2. Body weight ≥40 kg, BMI between 15 to 38 kg\u002Fm².\n3. Diagnosis of primary IgA nephropathy confirmed by renal biopsy within 8 years before screening or during screening.\n4. 24-hour urine protein excretion (24h-UPE) ≥0.75 g\u002F24h, or first morning void (FMV) urine protein-to-creatinine ratio (UPCR) ≥0.8 g\u002Fg.\n5. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73m².\n6. Previously vaccinated with ACYW135 meningococcal polysaccharide vaccine and pneumococcal vaccine.\n7. Received renin-angiotensin system (RAS) inhibitor therapy for at least 12 weeks prior to randomization, with stable treatment at the maximum recommended dose or maximum tolerated dose of RAS inhibitors for at least 4 weeks prior to randomization.\n8. Agreement to use at least one effective contraceptive method with partners during sexual activity from signing the informed consent form until 4 weeks after the last administration of the investigational product, and refrain from sperm\u002Fegg donation during this period.\n\nExclusion Criteria:\n\n1. Receipt of aldosterone receptor antagonists, renin inhibitors, or medications significantly affecting creatinine levels within 4 weeks or 5 half-lives (whichever is longer) before first investigational product administration.\n2. Continuous use of systemic corticosteroids, immunosuppressants\u002Fmodulators, or Chinese herbal medicines with immunosuppressive effects within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.\n3. Treatment with biological agents or complement pathway inhibitors (other than the study drug) within 12 weeks or 5 half-lives (whichever is longer) before first investigational product administration.\n4. History of gastrointestinal surgery potentially altering drug absorption\u002Fdistribution\u002Fmetabolism\u002Fexcretion, severe gastrointestinal disorders, or conditions causing dysphagia\u002Frecurrent vomiting that may interfere with oral medication intake.\n5. Major trauma\u002Fsurgery within 12 weeks before screening or planned major surgery during the study.\n6. Previous bone marrow\u002Fhematopoietic stem cell transplantation or solid organ transplantation (e.g., heart, lung, kidney, liver).\n7. Known\u002Fsuspected hereditary complement deficiency, or diagnosed primary\u002Fsevere secondary immunodeficiency.\n8. Poorly controlled blood pressure as assessed by the investigator.\n9. Poorly controlled blood glucose as assessed by the investigator.\n10. Presence of nephrotic syndrome, rapidly progressive glomerulonephritis, renal pathology showing \\>50% glomerular crescents, or \\>50% tubular atrophy-interstitial fibrosis.\n11. Participation in other interventional clinical trials with pharmacological\u002Fdevice interventions within 4 weeks before screening.\n12. Pregnant\u002Flactating women or those planning pregnancy during the study",{"count":167,"type":21},80,[51],"NTQ5082 is a small molecule inhibitor of complement factor B (CFB) that inhibits the enzymatic activity of CFB, thereby blocking the alternative pathway of the complement activation cascade. It is being clinically developed for the treatment of primary IgA nephropathy The main objectives of the study were to assess the efficacy and safety of NTQ5082 capsules in the treatment of patients with primary IgA nephropathy.",[27],"2025-05-20",{"date":173,"type":32},"2025-05-21",{"date":175,"type":21},"2025-05",{"date":177,"type":21},"2026-09",{"name":179,"class":39},"Nanjing Chia-tai Tianqing Pharmaceutical"]