[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"iga-nephropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:iga-nephropathy":656},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,52,79,103,137,166,196,225,260,283,308,331,350,374,403,421,442,468,501,521,543,564,585,605,634],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100634561","phase-2-a-study-of-jade101-in-participants-with-immunoglobulin-a-nephropathy-100634561",false,"NCT07541287","A Study of JADE101 in Participants With Immunoglobulin A Nephropathy","A Phase 2, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of JADE101 in Participants With Immunoglobulin A Nephropathy (JUNIPER)","Inclusion Criteria:\n\n1. Male or female participants 18-60 years of age, inclusive, and of local legal consenting age at the time of signing the informed consent\n2. eGFR ≥ 30 mL\u002Fmin\u002F1.73 m2\n3. Biopsy-confirmed primary IgAN\n4. Receiving stable and maximally tolerated doses of either ACEi or ARB as per standard of care (SoC) and applicable guidelines for at least 12 weeks prior to the initial screening visit, with no intention to alter the dose or discontinue treatment, unless medically necessary\n5. UPCR ≥ 0.75 g\u002Fg\n6. Willing to provide written informed consent\n7. Willing and able to comply with scheduled study visits, treatment plans, laboratory tests, and other study procedures\n8. Willing and able to comply with contraceptive and lifestyle requirements\n\nExclusion Criteria:\n\n1. Secondary forms of IgAN\n2. Known or suspected coexisting Chronic Kidney Disease (CKD) other than IgAN\n3. Known or suspected rapidly progressive glomerulonephritis (RPGN)\n4. Evidence of pathological findings in the kidney biopsy in addition to IgAN (eg, minimal change disease, diabetic kidney disease, membranous nephropathy, focal segmental glomerulosclerosis, or lupus nephritis); hypertensive vascular changes are acceptable\n5. Known or suspected primary or secondary immunodeficiency disorder\n6. Evidence of tuberculosis infection at screening\n7. Any chronic infectious disease\n8. Any acute infectious disease at time of screening\n9. Received bone marrow, hematologic stem cell transplantation, or a solid organ transplant, including kidney\n10. Known or suspected alcohol or drug abuse\n11. Any clinically significant and\u002For unstable or uncontrolled medical condition as assessed by the investigator\n12. Malignancy within the past 5 years; nonmelanoma skin cancer and curatively treated cervical carcinoma in situ are allowed\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","ALL","18 Years","60 Years",{"count":5,"type":21},"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This open-label Phase 2 study will characterize the safety and efficacy of JADE101 in participants with IgA nephropathy, and the results will contribute to the overall clinical characterization of JADE101 in this patient population.",[27],"IgA Nephropathy",[29,30,31,32,33,34,35,36,37,38],"Glomerulonephritis","Nephritis","Nephropathy","Kidney Diseases","Urologic Diseases","Urogenital Diseases","Autoimmune Diseases","Immune System Diseases","Proteinuria","Glomerulonephritis, IGA","RECRUITING","2026-08-18",{"date":42,"type":43},"2026-08-20","ACTUAL",{"date":45,"type":43},"2026-05-19",{"date":47,"type":21},"2029-04",{"name":49,"class":50},"Jade Biosciences, Inc.","INDUSTRY",15,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":61,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100428414","the-chinese-registry-of-prognostic-study-of-iga-nephropathy-crpiga-100428414","NCT04858724","The Chinese Registry of Prognostic Study of IgA Nephropathy (CRPIGA)","Construction of a Multi-center Database for Primary IgA Nephropathy","Inclusion Criteria:\n\n1. No age limit, no gender limit;\n2. Kidney biopsy confirmed primary IgA nephropathy;\n3. Sign the informed consent form voluntarily\n\nExclusion Criteria:\n\n1. IgA nephropathy is secondary to systemic diseases such as systemic lupus erythematosus and allergic purpura;\n2. IgAN is clinically diagnosed but not confirmed by pathology;\n3. The patient refuses to participate;\n4. Patients judged by other investigators to be unsuitable for inclusion in the study.",{"count":60,"type":21},2000,"12 Months","OBSERVATIONAL","1. Establish an IgAN cohort collaboration group and expert committee to carry out registration research.\n2. Construct IgAN structured data set standards, formulate structured data collection templates of diagnosis and treatment , and establish multi-center data integration systems on this basis.\n3. Establish a standardized IgAN database for combined Hospital Information System and the big data platform of the Medical Federation.\n4. Develop IgAN database managements and open standards for data sharing, and carry out high-quality clinical or basic research.",[27],[66,67,68],"IgAN","database","multicenter","2026-08-17",{"date":40,"type":43},{"date":72,"type":43},"2020-12-01",{"date":74,"type":21},"2027-12-30",{"name":76,"class":77},"Ruijin Hospital","OTHER",1,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100652123","phase-3-trial-of-sibeprenlimab-in-children-and-adolescents-with-immunoglobulin-a-nephropathy-igan-100652123","NCT07770815","Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)","A Phase 3, Open-label, Single-arm, Repeat-dose Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Sibeprenlimab Administered Subcutaneously in Children and Adolescents With Immunoglobulin A Nephropathy","1. Source-verified, biopsy-confirmed IgA nephropathy (IgAN).\n2. Receiving a stable and maximally tolerated dose of authorized angiotensin converting enzyme inhibitors (ACEIs) and\u002For angiotensin receptor blockers (ARBs) for at least 12 weeks.\n3. Participants receiving a stable dose of sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy for IgAN, if available, in addition to ACEIs and\u002For ARBs, must have initiated SGLT2i treatment for at least 12 weeks.\n4. Participants must have a urine protein\u002Fcreatinine ratio (uPCR) ≥ 0.75 grams per gram (g\u002Fg), as measured from the geometric mean of 3 first void spot urine samples (collected within the screening window prior to Dose 1).\n5. Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2).\n6. No evidence of coexisting chronic kidney disease other than IgAN.\n7. Serum immunoglobulin G (IgG) ≥ 600 mg\u002FdL at screening.\n8. Kidney biopsy findings not demonstrating additional pathological features inconsistent with IgAN.","2 Years","17 Years",{"count":89,"type":21},24,[91],"PHASE3","This Phase 3, open-label study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of sibeprenlimab administered subcutaneously every 4 weeks in pediatric participants aged 2 to 17 years with IgA nephropathy (IgAN). Sibeprenlimab will be administered as an add-on to standard of care therapy consisting of angiotensin converting enzyme inhibitors (ACEIs) and\u002For angiotensin receptor blockers (ARBs).",[27],"NOT_YET_RECRUITING","2026-08-13",{"date":40,"type":43},{"date":98,"type":21},"2026-09-30",{"date":100,"type":21},"2030-02-23",{"name":102,"class":50},"Otsuka Pharmaceutical Development & Commercialization, Inc.",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":86,"maxAge":18,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":121,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100631258","phase-3-study-to-assess-the-efficacy-pharmacokinetics-safety-and-tolerability-of-atrasentan-in-pediatric-patients-with-primary-igan-100631258","NCT07498335","Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN","A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients of 2 to \u003C18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)","ADVANCE","Inclusion Criteria:\n\n1. Signed informed consent by parent(s)\u002Flegal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed. A consent or assent may also be required for some participants depending upon their age and local requirement.\n2. Male and female participants 2 to \\\u003C 18 years of age as of Day 1.\n3. eGFR ≥ 30 mL\u002Fmin\u002F1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.\n4. Kidney biopsy-proven primary IgAN\\*, with biopsy performed within 3 years of Screening with \\\u003C 50% tubulointerstitial fibrosis and \\\u003C 25% crescents. In case a kidney biopsy within 3 years from Screening is not available, a kidney biopsy may be performed if it is part of the planned diagnostic approach and clinical management of the participant.\n5. Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g\u002Fg (113 mg\u002FmmoL) sampled from FMV at Screening on Day -90 and Day -60 as well as during the Run-in Period despite treatment with maximum tolerated dose of ACE inhibitor\u002FARB for at least 120 days prior to Day 1. Note: UPCR will be assessed based on one FMV sample at Day -90 and based on the geometric mean of 2 FMV samples for the Day -60 visit and during the Run-in Period.\n6. All participants must have been on supportive care including stable dose regimen of ACE inhibitor or ARB at either the locally approved maximal daily dose per body weight, or the maximally tolerated dose (per Investigator's judgment for pediatric use), for at least 120 days before first study drug administration. In addition, if participants are taking diuretics, other antihypertensive medication, or other background medication for IgAN (such as SGLT2 inhibitors), the doses should also be stabilized for at least 120 days prior to the first dosing of study treatment. Note: Participants with allergies or intolerance to ACE inhibitors and ARBs are eligible for the study. Participants with allergies or intolerance to RAS inhibitors are eligible but will not exceed \\~5% of the total population treated (maximum of 2 participants).\n7. The minimum body weight of enrolled pediatric participants is 10 kg at Screening and confirmed on Day 1.\n8. Parent(s)\u002Fguardian(s) are to be able to communicate well with the investigator and to understand and comply with the study's requirements for their child.\n\nExclusion Criteria:\n\n1. Participation in any other investigational drug trial or use of other investigational drugs at the time of enrollment, or within 5 elimination half-lives of enrollment, or within 30 days of enrollment, whichever is longer; or longer if required by local regulations.\n2. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.\n3. Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, Herpes Simplex virus infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, and familial mediterranean fever before treatment.\n4. A clinical diagnosis of IgA vasculitis (IgAV or Henoch-Schoenlein purpura) based on typical palpable purpura with or without arthralgia and abdominal pain.\n5. Evidence of significant urinary obstruction or difficulty in voiding, any urinary tract disorder causing significant urinary obstruction or difficulty in voiding at Screening and confirmed at Baseline\u002FDay 1.\n6. Concurrent diagnosis of CKD other than IgAN at Screening and before first study drug administration.\n7. Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of Screening.\n8. Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to Screening or during Screening and Run-in periods.\n9. Presence of nephrotic syndrome at Screening based on the investigator's judgement.\n10. BNP value of \\>200 pg\u002FmL at Screening.\n11. Hemoglobin below 9 g\u002FdL at Screening or prior history of blood transfusion for anemia within 3 months of Screening.\n12. Platelet count \\\u003C80,000\u002FμL at Screening.\n13. On Day 1 participants' body weight falls below the lower limit of the cohort in which the participant was initially screened and lower body weight cohort is not open for enrollment.\n14. Known history of congenital heart disease, heart failure or clinically significant fluid retention such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites before treatment.\n15. Current use of any homeopathic and\u002For herbal medications for the treatment of IgAN disease , such as but not limited to Tripterygium wilfordii (Lei Gong Teng), Caulis sinomenii and Sinomenium acutum before treatment.\n16. History of an alcohol or illicit drug-related disorder within the past 3 years at Screening.\n17. Confirmed blood pressure \\>150 mmHg systolic or \\>95 mmHg diastolic for 12 to \\\u003C18 years of age; \\>140 mmHg systolic or \\>90 mmHg diastolic for 6 to \\\u003C12 years of age; \\>120 mmHg systolic or \\>80 mmHg diastolic for 2 to \\\u003C6 years of age; based on the mean of 3 measurements obtained at Screening; or clinically significant hypotension at screening.\n18. Participants previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), calcineurin inhibitors, complement inhibitors, oral budesonide in any dose, systemic corticosteroid exposure ≥0.5 mg\u002Fkg\u002Fday or \\> 7.5 mg total exposure in a single day of prednisone\u002Fprednisolone equivalent within 120 days (or 180 days for rituximab) prior to first study drug administration.\n\n    Participants treated with endothelin (receptor) antagonists (including sparsentan) within 120 days prior to first study drug administration.\n19. History of organ transplantation (subjects with history of corneal transplant are not excluded) before treatment.\n20. Major concurrent comorbidities before treatment including but not limited to advanced cardiac disease (e.g., NYHA class III (for ages 6 to \\\u003C18 years), Ross class III (for ages 2 to \\\u003C6years)), severe pulmonary disease (e.g., WHO class III (for age 17 years); Pulmonary Vascular Research Institute (PVRI) class III (for 2-\\\u003C17 years)), or hepatic disease (e.g., active hepatitis) that in the opinion of the investigator precludes subject's participation in the study.\n21. Any medical condition deemed likely to interfere with the subject's participation in the study before treatment.\n22. Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.\n23. Presence of fever ≥ 38°C (100.4°F) within 7 days prior to study drug administration.\n24. Human immunodeficiency virus (HIV) infection (known history of HIV or test positive for HIV antibody at Screening).\n25. Liver disease, such as active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as Hepatitis B surface antigen (HBsAg) positive or Hepatitis C virus ribonucleic acid (HCV-RNA) positive at Screening, or liver injury as indicated by abnormal liver function tests at Screening and Baseline as defined below:\n\n    * Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3X upper limit of normal (ULN)\n    * Serum bilirubin must not exceed 2X ULN\n26. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer treated with curative intent), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases; for children aged 2 to \\\u003C5 years of age, history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, inclusive of malignancies diagnosed at birth and during the neonatal and childhood time, regardless of whether there is evidence of local recurrence or metastases.\n27. Pregnant or nursing (lactating) female participants (of childbearing potential), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test at Screening.\n28. Subjects taking prohibited therapies before treatment.\n29. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for 1 month after stopping study treatment.\n\nHighly effective contraception methods include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n* Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.\n* Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks before taking study treatment).\n* Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to screening provided partner(s) has(have) received medical confirmation of surgical success.\n* Use of hormonal contraception methods:\n* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal.\n* Progestogen-only hormonal contraception (where inhibition of ovulation is not the primary or only mode of action): oral, injectable or implantable.\n* Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study treatment. If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF. 30. For fertile male participants, participants must not intend to father a child or donate sperm while taking study treatment and at least 1 month afterward for males.\n* All fertile male participants in a sexual relationship with a WOCBP must agree to the use of a condom during the trial and for up to one month after last study drug administration. A male participant is considered fertile after puberty unless permanently sterile by bilateral orchidectomy\u002Forchiectomy.",{"count":112,"type":21},28,[91],"A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to \\\u003C18 years with primary immunoglobulin A nephropathy (IgAN).",[116,117,27,118,119,120],"Berger Disease","Bergers Disease","Immunoglobulin A Nephropathy","Primary IgAN","Nephritis IgA Type, Nephropathy IgA Type",[32,122,29,33,123,38,124,125,126],"Kidney Disease, Chronic","Glomerular Disease","Glomerulopathy","Immunoglobulin Disease","Atrasentan","2026-08-06",{"date":129,"type":43},"2026-08-07",{"date":131,"type":21},"2026-08-26",{"date":133,"type":21},"2032-12-13",{"name":135,"class":50},"Novartis Pharmaceuticals",9,{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":144,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100548300","phase-2-a-phase-2-study-to-evaluate-the-safety-pd-pk-and-clinical-activity-of-adx-097-in-participants-with-igan-ln-or-c3g-100548300","NCT06419205","A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G","A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)","Key Inclusion Criteria:\n\nAll participants\n\n1. Male or female participants aged ≥16 years.\n2. uPCR ≥0.5 g\u002Fg (from the average of 3 first morning voids \\[FMVs\\]).\n3. Screening eGFR ≥30 mL\u002Fmin\u002F1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).\n4. Participants receiving a renin-angiotensin-aldosterone system (RAAS) inhibitor, sodium-glucose cotransporter-2 (SGLT2) inhibitor, sparsentan, or atrasenten must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 8 weeks prior to Study Day 1 and the dose is projected to remain stable until completion of the study.\n\n   Participants with IgAN only\n5. Kidney biopsy-proven diagnosis of IgAN with a kidney biopsy that is obtained within 10 years of Day 1 or within 5 years of Day 1 if the participant is known or suspected of also having diabetic nephropathy.\n\n   Participants with LN only\n6. Clinical diagnosis of systemic lupus erythematosus (SLE)\n7. Kidney biopsy-proven diagnosis of LN with a kidney biopsy that is obtained within 24 weeks of Day 1.\n8. Diagnosis of active focal or diffuse LN class III or IV\n\n   Participants with C3G only\n9. Kidney biopsy-proven diagnosis of C3G, either dense deposit disease (DDD) or complement component 3 glomerulonephritis (C3GN), with a kidney biopsy that is obtained within 52 weeks of Day 1.\n10. Participants receiving mycophenolate mofetil (MMF) (or mycophenolic acid) or prednisone ≥10 mg\u002Fd or equivalent must have been on a stable dose for at least 12 weeks before Day 1 that is projected to remain stable until completion of the study.\n\nKey Exclusion Criteria All participants\n\n1. Rapidly progressive glomerulonephritis defined as a 50% decline in eGFR within 12 weeks of screening.\n2. Concomitant significant renal disease other than IgAN, C3G, or LN per investigator discretion.\n3. Participants with a history of and\u002For presence of anti-factor H antibodies at screening.\n4. Uncontrolled hypertension with mean seated systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg based on the average of 2 measurements obtained at approximately 2-minute intervals after the individual has been sitting for 5 minutes.\n5. Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.\n6. History of splenectomy.\n\n   Participants with IgAN only\n7. Secondary forms of IgAN\n8. Received systemic corticosteroid therapy, oral budenoside, or any other form of immunosuppressive therapy within 12 weeks before Day 1.\n\n   Participants with LN only\n9. Lymphocyte count below 0.5 × 109\u002FL at screening.\n10. Received any of Cyclophosphamide, Calcineurin inhibitors, IV methylprednisolone, IV immunoglobulin therapy, Belimumab, Obinutuzumab and Rituximab treatments at protocol specified time points.\n\n    Participants with C3G only\n11. Evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary.\n12. Received systemic corticosteroid therapy, eculizumab, iptacopan, pegcetacoplan, or any other form of immunosuppressive therapy ≤12 weeks before Day 1, except for MMF (or mycophenolic acid), which is permitted.","16 Years",{"count":5,"type":21},[24],"A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)",[27,149,150],"Lupus Nephritis (LN)","C3 (Complement Component 3) Glomerulopathy",[118,152,153,154,155],"Lupus Nephritis","Complement Component 3 Glomerulopathy","ADX-097","C3G","2026-08-03",{"date":158,"type":43},"2026-08-04",{"date":160,"type":43},"2026-07-30",{"date":162,"type":21},"2028-02",{"name":164,"class":50},"Akebia Therapeutics",2,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":78},"100608580","early-phase-1-a-study-of-anti-cd19bcma-universal-car-t-cell-therapy-rd06-05-in-patients-with-autoimmune-diseases-100608580","NCT07203404","A Study of Anti-CD19\u002FBCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.","A Clinical Study of the Safety, Efficacy, and Cell Pharmacokinetics of Anti-CD19\u002FBCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Aged ≥18 years and ≤75 years.\n3. Adequate organ function defined as:\n\n   1. Bone marrow function: Defined as absolute neutrophil count (ANC) ≥1500\u002FμL, absolute lymphocyte count (ALC) ≥100\u002FμL, hemoglobin (Hb) ≥80 g\u002FL, and platelet count (PLT) ≥50,000\u002FμL. Transfusions and growth factors must not have been used within 7 days prior to screening to meet these criteria.\n   2. Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN), and total bilirubin \\\u003C1.5 × ULN (or \\\u003C3.0 × ULN for subjects with Gilbert's syndrome).\n   3. Coagulation function: Defined as international normalized ratio (INR) or partial thromboplastin time (PTT) ≤1.5 × ULN.\n   4. Pulmonary function: Defined as dyspnea ≤ Grade 1 per CTCAE and oxygen saturation (SpO₂) ≥92% on room air (by pulse oximetry).\n4. Female subjects of childbearing potential must have a negative serum or urine pregnancy test. Females who are surgically sterile or postmenopausal for at least 2 years are considered not of childbearing potential.\n5. From the time of signing the informed consent form until 6 months after the completion of RD06-05 infusion, female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective methods of contraception.\n\nInclusion Criteria for Subjects with Anti-GBM Disease:\n\nDiagnosis of anti-GBM disease according to the 2012 Chapel Hill Consensus Conference definitions, meeting both of the following criteria:\n\n1. Positive for anti-GBM antibody (based on historical or screening test results);\n2. Evidence of renal involvement at screening, defined as:\n\n   1. Presence of active, pathologically confirmed anti-GBM disease (renal biopsy must have been performed within 1 year prior to the screening visit or during the screening period); and\n   2. Accompanied by proteinuria and hematuria.\n\nInclusion Criteria for Subjects with SLE\u002FLN:\n\n1. Diagnosis of SLE according to the 2019 European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.\n2. Positive for antinuclear antibody (ANA), and\u002For anti-double-stranded DNA (anti-dsDNA) antibody, and\u002For anti-Smith (anti-Sm) antibody at screening.\n3. SLEDAI-2K score \\> 6 points at screening.\n\nInclusion Criteria for Subjects with AAV\u002FAAGN:\n\n1. Diagnosis of microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) according to the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis.\n2. Positive for anti-myeloperoxidase (MPO-ANCA) antibody or anti-proteinase 3 (PR3-ANCA) antibody at screening or based on historical testing.\n3. For AAV without renal involvement: A Birmingham Vasculitis Activity Score (BVAS) version 3 score of ≥3 at screening, indicating active vasculitis.\n\nInclusion Criteria for Subjects with MN:\n\n1. Diagnosis of primary (idiopathic) membranous nephropathy confirmed by renal biopsy pathology (the renal biopsy must have been performed within 2 years prior to screening or during the screening period).\n2. Meeting the criteria for high-risk or relapsed\u002Frefractory membranous nephropathy:\n\nHigh-risk patients, defined as meeting any of the following criteria:\n\n1. Normal eGFR with urine protein \\>3.5g\u002F24h, a reduction of \\\u003C50% in urine protein after 6 months of ACEI\u002FARB treatment, and serum albumin \\\u003C25 g\u002FL or anti-PLA2R antibody \\>50 RU\u002FmL;\n2. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² and\u002For urine protein \\>8g\u002F24h for more than 6 months.\n\nRefractory\u002FRelapsed patients:\n\nRefractory patients are defined as those resistant to prior immunosuppressive therapy (persistent urine protein ≥3.5g\u002F24h with a \\\u003C50% reduction from baseline).\n\nRelapsed patients are defined as those who achieved complete or partial remission with prior immunosuppressive therapy but subsequently developed recurrent urine protein ≥3.5g\u002F24h.\n\nInclusion Criteria for Subjects with SSC:\n\n1. Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria.\n2. Diagnosis of diffuse cutaneous SSc at screening.\n\nInclusion Criteria for Subjects with IIM:\n\n1.Diagnosis of idiopathic inflammatory myopathy (IIM) according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, corresponding to a probability score of ≥55%). The subtypes include dermatomyositis (DM), anti-synthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).\n\nInclusion Criteria for Subjects with IgAN:\n\n1. Definitive diagnosis of primary IgA nephropathy confirmed by renal biopsy pathology results obtained within 2 years prior to screening.\n2. At screening, 24-hour urinary protein ≥1 g\u002F24 h, or urine protein-to-creatinine ratio (UPCR) ≥0.75 g\u002Fg.\n3. At screening, estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m².\n4. Standard therapy must have been completed for a minimum of 3 months before screening, with a stable drug dose maintained for at least 4 weeks; standard therapeutic agents include ACEIs, ARBs, and\u002For SGLT2 inhibitors.\n5. At screening, the subject's blood pressure shall be controlled at ≤150\u002F90 mmHg.\n\nExclusion Criteria:\n\n1. Subjects with SLE\u002FLN:\n\n   1. Severe active central nervous system (CNS) lupus, including psychosis, seizures, lupus headache, or other signs\u002Fsymptoms associated with neuropsychiatric lupus, as assessed by a qualified specialist during screening.\n   2. Drug-induced or secondary lupus.\n2. Subjects with AAV\u002FAAGN:\n\n   1. Drug-induced or secondary AAV\u002FAAGN.\n   2. Presence of alveolar hemorrhage requiring invasive ventilatory support at screening.\n3. Subjects with Anti-GBM Disease:\n\n   1. Anuria for more than 7 days.\n   2. Dialysis dependence for more than 30 days.\n   3. Ongoing moderate or severe pulmonary hemorrhage (or cessation within the past two weeks) defined as pulmonary hemorrhage requiring assisted ventilation, supplemental oxygen, or blood transfusion.\n   4. Symptomatic congestive heart failure (NYHA Class 2-4) requiring prescription medication or clinically significant cardiogenic peripheral edema.\n4. Subjects with MN:\n\n   Secondary membranous nephropathy.\n5. Subjects with IIM:\n\n   Presence of severe rhabdomyolysis or CK level ≥120 × ULN at screening.\n6. Subjects with SSc:\n\n   1. History of scleroderma renal crisis within 1 year prior to screening.\n   2. History of cardiac tamponade within 6 months prior to screening.\n   3. Active infection of digital ulcers within 3 months prior to screening.\n   4. Presence of digital gangrene at screening.\n7. Subjects with IgAN:\n\n   1. Patients with secondary IgA nephropathy induced by Henoch-Schönlein purpura, systemic lupus erythematosus, hepatitis, infection, or other conditions.\n   2. Subjects concurrently diagnosed with other etiologies of chronic kidney disease, including but not limited to diabetic nephropathy or other primary glomerulopathies, if the Investigator judges such conditions may increase risks or confound efficacy assessment, will be excluded.\n   3. Renal biopsy pathology showing renal tubular atrophy or interstitial fibrosis ≥75%; or global glomerulosclerosis involving ≥75% of glomeruli.","75 Years",{"count":175,"type":21},96,[177],"EARLY_PHASE1","An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19\u002FBCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE\u002FLN, AAV\u002FAAGN, Anti-GBM, MN, SSc, and IIM).",[180,181,182,183,184,185,186,187,27],"SLE","LN","ANCA Associated Vasculitis","ANCA-Associated Glomerulonephritis","Anti-GBM Disease","MN","SSc","IIM","2026-07-31",{"date":156,"type":43},{"date":191,"type":43},"2025-07-24",{"date":193,"type":21},"2028-07-23",{"name":195,"class":50},"Nanjing Bioheng Biotech Co., Ltd.",{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":206,"conditions":207,"keywords":213,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":78},"100593731","epithelial-dysmetabolism-and-renal-fibrosis-in-anca-vasculitis-100593731","NCT07010250","Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis","PROTECT-Fi","Inclusion Criteria:\n\n* Patients with an indication for initial diagnostic PBR on native kidney\n* 18 ans ≥ Age ≤ 90 ans\n* Affiliation to french health insurance\n* Patient having given consent\n\nFor the ANCA vasculitis group:\n\n• Diagnosis of ANCA vasculitis retained on renal biopsy with ANCA anti-proteinase 3 (PR3) or ANCA anti-myeloperoxidase (MPO)\n\nFor the control groups:\n\n• Diagnosis retained after the renal biopsy\n\n* Interstitial Nephritis\n* Or glomerular nephropathy such as minimal change nephropathy\n* Or Segmental hyalinosis in itscollapsing form\n* Or Extramembranous Glomerulopathy,\n* Or glomerulopathy with mesangial IgA deposits\n* Or diabetic nephropathy.\n\nExclusion Criteria:\n\n* Kidney transplant patient\n* Patient on dialysis (hemodialysis or peritoneal dialysis)\n* Patient under legal protection, guardianship or curatorship\n* Pregnancy or breastfeeding\n* Enrollement in an interventional study except studies relating to ANCA vasculitis and nephropathy with mesangial IgA deposits.","90 Years",{"count":205,"type":21},146,"The project is to explore in humans the hypothesis of the link between the alteration of tubulo-interstitial metabolism and the rate of deterioration of renal function by comparing various nephropathies.",[182,208,209,210,27,211,212],"Extramembranous Glomerulopathy","Nephrotic Syndrome, Minimal Change","Interstitial Nephritis","Segmental Hyalinosis","Diabetic Nephropathies",[214,215],"nephropathy","cohort","2026-06-29",{"date":218,"type":43},"2026-06-30",{"date":220,"type":43},"2025-11-03",{"date":222,"type":21},"2029-11-02",{"name":224,"class":77},"Assistance Publique - Hôpitaux de Paris",{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":51},"100597145","phase-1-study-of-bhv-1400-in-iga-nephropathy-100597145","NCT07054684","Study of BHV-1400 in IgA Nephropathy","An Open-Label Biomarker Study of BHV-1400 in IgA Nephropathy","Key Inclusion Criteria:\n\n1\\. Participants must have biopsy-confirmed IgA Nephropathy\n\nKey Exclusion Criteria:\n\n1. Any secondary IgAN\n2. Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause","65 Years",{"count":234,"type":21},20,[236],"PHASE1","The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).",[27],[66,240,241,242,243,244,245,246,247,248,249,250],"proteinuria","glomerulonephropathy","chronic kidney disease","kidney disease","CKD","nephritis","urologic disease","glomerulonephritis","Glomerular disease","Iga nephropathy","renal disease","2026-06-19",{"date":253,"type":43},"2026-06-23",{"date":255,"type":43},"2025-07-30",{"date":257,"type":21},"2027-07",{"name":259,"class":50},"Biohaven Therapeutics Ltd.",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":270,"briefSummary":271,"conditions":272,"keywords":273,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":4},"100643535","phase-3-a-study-to-determine-if-bhv-1400-is-effective-and-safe-in-adults-with-iga-nephropathy-100643535","NCT07642050","A Study to Determine if BHV-1400 is Effective and Safe in Adults With IgA Nephropathy","A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BHV-1400 in the Treatment of IgA Nephropathy","Key Inclusion Criteria:\n\n* Diagnosis of IgAN as confirmed by renal biopsy conducted within 10 years prior to Screening.\n\n  * If a participant has a history of diabetes, the biopsy must have been conducted within 2 years prior to Screening with no evidence of diabetic nephropathy.\n  * In all cases, if a historical biopsy report is not available, a biopsy may be performed prior to Screening.\n* UPCR ≥ 0.75 g\u002Fg or UPE ≥ 1.0 g\u002Fd determined via 24 hour collection.\n* eGFR ≥ 30 mL\u002Fmin\u002F1.73m2 (CKD-EPI equation).\n* Participants must have been on supportive care including a stable dose regimen of ACEi or ARB (at the locally approved maximal daily dose or the maximally tolerated dose per Investigators' judgment) for at least 90 days prior to Screening. Subjects who are not able to tolerate ACEi or ARB therapy may be eligible for participation in the trial if their overall management including blood pressure control is as per local applicable guidelines. This must be discussed with the medical monitor and documented by the Investigator.\n* Patients may be on a dual endothelin angiotensin receptor antagonist (DEARA) or endothelin receptor antagonist (ERA) but must be on a stable dose for at least 90 days prior to Screening and they must remain on a stable dose throughout the course of the study. Participants may be on a sodium-glucose cotransporter 2 (SGLT2) inhibitor, mineralocorticoid receptor antagonist (including Finerenone), but must be on a stable dose for 90 days prior to Screening and must remain on a stable dose throughout the course of the study.\n\nKey Exclusion Criteria:\n\n* Any secondary IgAN as defined by the Investigator; secondary IgAN can be associated with cirrhosis, celiac disease, HIV infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, familial Mediterranean fever, etc. NOTE: IgA Vasculitis excluded if patient has had any IgA Vasculitis related extrarenal signs or symptoms, or requirement for steroid or other immunosuppressive therapy in the past year.\n* Any cause of chronic kidney disease that is not diagnosed as IgAN or may be due to non-IgAN cause, such as diabetic nephropathy. If presence of other kidney disease or concurrent glomerulopathies felt to be non-dominant, consideration for inclusion must be discussed with and approved by the Sponsor Medical Monitor\u002FSponsor Designee.\n* Presence of rapidly progressive glomerulonephritis as defined by 50% decline in eGFR within 3 months prior to Screening.\n* Evidence of nephrotic syndrome, defined as 24-hour protein \\> 3.5g with concurrent hypoalbuminemia (Albumin \\\u003C 3.0 g\u002Fdl), within 6 months of Screening\n* End-stage renal disease requiring dialysis or transplantation","70 Years",{"count":269,"type":21},420,[91],"The purpose of this study is to determine if BHV-1400 is effective and safe in the treatment of IgA Nephropathy. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.",[27],[66,274,31,240,241,244,245,246,247,248,249,250,243],"Chronic Kidney disease","2026-06-08",{"date":277,"type":43},"2026-06-11",{"date":279,"type":21},"2026-06",{"date":281,"type":21},"2029-10",{"name":259,"class":50},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":296,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100543035","phase-2-therapeutic-effect-of-hydroxychloroquine-on-immunoglobulin-a-iga-nephropathy-course-quigan-study-100543035","NCT06350630","Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study","Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA)Nephropathy Course QUIgAN Study","QUIgAN","Inclusion Criteria:\n\n* Social security affiliation\n* Signed informed consent\n* With biopsy proven IgA nephropathy (any vintage)\n* With at least one Oxford lesion (M, E, S, T, C) on last available kidney biopsy - With urine albumin\u002Fcreatinine \\> 300mg\u002Fg,\n* under maximal tolerated labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors for at least 3 months\n* Sodium-Glucose Transport Protein 2 (SGLT-2) inhibitors initiated at least 1 month before inclusion visit\n* Only patients treated with SGLT2i and RAAS dual therapy before inclusion\n* With estimate GFR above 15 mL\u002Fmin\u002F1,73m² (Chronic Kidney Disease - EPIdemiology collaboration CKD-EPI formula)\n* Woman in childbearing with a highly effective method of contraception\n* Agreement of woman in childbearing potential (WOCBP) to perform a urine pregnancy test every month until three months after the end of study treatment\n* Agreement of fertile male with WOCBP partner to use a condom for the duration of the study treatment up to 3 months after treatment the end of study treatment.\n\nExclusion Criteria:\n\n* Secondary IgA nephropathy (Henoch Schonlein purpura, cirrhosis, inflammatory bowel disease)\n* Corticosteroid or immunosuppressive therapies in the past year before screening\n* Contra-indication to hydroxychloroquine (retinopathy, maculopathy, history of intolerance to hydroxychloroquine…)\n* Uncontrolled hypertension (systolic blood pression\\> 160 mmHg and\u002For diastolic blood pression \\>110 mmHg )\n* Long QT interval and\u002For QT prolonging medicines\n* Pregnancy or lactation",{"count":292,"type":21},334,[24],"immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity.\n\nIn this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus Erythematosus) and very low priced.\n\nOne randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group).\n\nConsidering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study.",[27],[297,240],"Hydroxychloroquine","2026-06-01",{"date":300,"type":43},"2026-06-03",{"date":302,"type":43},"2025-06-26",{"date":304,"type":21},"2030-12-31",{"name":306,"class":77},"Centre Hospitalier Universitaire de Saint Etienne",7,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":17,"minAge":315,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":78},"100282275","iga-nephropathy-biomarkers-evaluation-study-interest-100282275","NCT02954419","IgA Nephropathy Biomarkers Evaluation Study (INTEREST)","INTEREST","Inclusion Criteria:\n\n* Male or female individuals aged 14 years or older\n* Patients with biopsy-proven primary IgA nephropathy\n* A renal biopsy available for reviewing must include 10 or more glomeruli.\n* The first renal biopsy was performed within 3 years.\n* eGFR ≥ 60 ml\u002Fmin\u002F1.73 m2 (MDRD formula);\n* Individuals or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Relatives were diagnosed with biopsy-proven primary IgA nephropathy;\n* Individuals had secondary IgA nephropathy due to diseases such as diabetes, chronic liver disease and systemic lupus erythematosus.","14 Years",{"count":60,"type":21},"This prospective cohort study is designed to examine the association between blood and urine biomarkers (including genetic variants) and long-term kidney disease progression among 2000 Chinese IgA nephropathy patients with relatively normal kidney function (eGFR≥60 ml\u002Fmin\u002F1.73 m2).",[27,319],"Glomerular Diseases",[27,321],"Biomarker","2026-04-08",{"date":324,"type":43},"2026-04-13",{"date":326,"type":4},"2016-11",{"date":328,"type":21},"2027-01",{"name":330,"class":77},"Sun Yat-sen University",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":232,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":346,"leadSponsor":348,"locationsCount":4},"100550978","phase-2-study-of-nm8074-in-patients-with-immunoglobulin-a-nephropathy-igan-100550978","NCT06454110","Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)","A Phase II, Open-Label Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)","Inclusion Criteria:\n\n* Male and female patients ≥18 years of age at the time of consent.\n* A body mass index (BMI) within the range of 15 - 38 kg\u002Fm2. BMI = Body weight (kg) \u002F \\[Height (m)\\]2.\n* Confirmation of IgA Nephropathy verified by biopsy performed within the previous three years.\n* All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135. MenB meningococcal serogroup B vaccine (Bexsero®) will be administered per local guidelines.\n* Hemoglobin ≥ 10g\u002FdL and platelet count ≥ 100,000\u002Fmm3\n* Female and male participates must agree to use contraceptives\n\nExclusion Criteria:\n\n* Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with NM8074.\n* Require dialysis or plasma exchange within 12 weeks prior to screening.\n* Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy.\n* History of bone marrow, hematopoietic stem cells, or solid organ transplantation.\n* Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 3 months to study day 1 whichever is longer.\n* Severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (CKD stage 4, chronic dialysis).\n* Clinically significant abnormal ECG during screening.\n* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections.\n* Has a currently active or known history of meningococcal disease or N. meningitidis infection.\n* Clinically significant medical or psychological conditions or risk factors that, as per the Investigator's judgment, could hinder the patient's participation in the study, introduce additional risks for the patient, or complicate the evaluation of the patient or study outcomes.\n* Pregnant, planning to become pregnant, or nursing female subjects.\n* Females with a positive pregnancy test result at Screening or on Day 1.",{"count":339,"type":21},10,[24],"This is a Phase II, open-label study designed to To evaluate the safety and efficacy of NM8074 in reducing proteinuria relative to baseline in IgAN patients after 99 days of treatment.",[27],"2026-04-07",{"date":324,"type":43},{"date":162,"type":21},{"date":347,"type":21},"2031-12",{"name":349,"class":50},"NovelMed Therapeutics",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":360,"conditions":361,"keywords":362,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":4},"100629931","iga-nephropathy-insights-from-treatment-experience-among-patients-receiving-iptacopan-andor-atrasentan-using-primary-data-collection-100629931","NCT07481084","IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and\u002For Atrasentan Using Primary Data Collection","China IgNITE - Umbrella Protocol: IgA Nephropathy Insights From Treatment Experience Among Patients Receiving Iptacopan and\u002For Atrasentan Using Primary Data Collection","Inclusion criteria\n\n1. Biopsy confirmed diagnosis of IgAN.\n2. Age ≥18 years at index date.\n3. Eligible for treatment with iptacopan or atrasentan as per approved drug label and local regulations at the discretion of treating physician.\n4. Able to provide written consent for participation. a. Patients who withdraw their consent will be censored on this date; all aggregated and anonymised data collected up to that date will be included in a centralised IgNITE data platform.\n\nExclusion criteria\n\n1. Use of investigational drugs during the study, OR within 3 months before index date, OR within 5 half-lives of investigational drug before index date, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.\n2. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored study (NIS or interventional) with iptacopan\u002Fatrasentan.\n3. Known hypersensitivity or contraindications to iptacopan, atrasentan, or their excipients, as documented in the patient's medical records.\n4. Presence of significant comorbidities or conditions that may impact the interpretation of the study results or the patient's ability to participate in the study at the discretion of treating physician.\n5. Pregnancy or other contraindications for iptacopan and\u002For atrasentan\n6. Insufficient medical records available for the baseline and follow-up periods.","99 Years",{"count":359,"type":21},80,"The current prospective, non-interventional study (NIS) being conducted under the IgNITE umbrella protocol using primary data collection (PDC), aims to enhance understanding of real-world patient profiles, treatment patterns, and clinical outcomes among patients with IgAN treated with iptacopan or atrasentan in the real-world clinical care setting immediately from the time of drug launch. Furthermore, this study is planned to contribute to a global meta-analysis, to enable further analysis with greater statistical power, as well as exploration of similarities and differences of treatment use and outcomes between countries and regions. Each patient will be observed for 24 months",[27],[363,364,365],"China IgNITE","Iptacopan","atrasentan","2026-03-13",{"date":368,"type":43},"2026-03-18",{"date":370,"type":21},"2026-05-29",{"date":372,"type":21},"2029-03-30",{"name":135,"class":50},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":386,"conditions":387,"keywords":388,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":402},"100570835","phase-4-efficacy-and-safety-of-extended-tarpeyo-treatment-beyond-9-months-in-adult-patients-with-primary-iga-nephropathy-100570835","NCT06712407","Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy","An Open-label Study to Assess the Efficacy and Safety of Extended TARPEYO® (Delayed-release Budesonide Capsules) Treatment in Adult Patients With Primary IgA Nephropathy Who Have Completed 9 Months of TARPEYO® 16 mg Once Daily Treatment in Real-world Clinical Practice","NefXtend","Inclusion Criteria:\n\n1. Diagnosed IgAN with biopsy verification\n2. Female or male participants ≥18 years of age\n3. Completion of a single, initial 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visit\n4. Access to retrospective local laboratory assessment data on UPCR and serum creatinine. Available retrospective data should include at least 1 assessment timepoint within 3 months prior to the first dose of TARPEYO® commercial treatment.\n5. On stable treatment with renin-angiotensin system (RAS) inhibitor therapy or sparsentan for at least 8 weeks prior to the Baseline visit. A stable dose is defined as a dose within 25% of the dose at Baseline.\n6. If on current treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitor, the treatment should have been stable for at least 8 weeks prior to the Baseline visit. A stable dose is defined as a dose within 25% of the dose at Baseline.\n\nExclusion Criteria:\n\n1. Participants who have been treated with systemic immunosuppressive medications including glucocorticosteroids (GCS) other than TARPEYO® during the TARPEYO® commercial treatment period. Topical or inhalation products containing GCS or immunosuppressants are allowed.\n2. Presence of other glomerulopathies (e.g., C3 glomerulopathy, diabetes nephropathy and\u002For hypertensive nephropathy).\n3. Presence of nephrotic syndrome (i.e., proteinuria \\>3.5 g per day and serum albumin \\\u003C3.0 g\u002FdL, with or without edema).\n4. Presence of medical condition excluding continued TARPEYO® treatment, as assessed by the Investigator.\n5. On current or planned dialysis.\n6. Undergone kidney transplant.\n7. Poorly controlled diabetes mellitus or hypertension, as assessed by the Investigator.\n8. Participants with known osteoporosis in the medium- or high-risk category according to the 2010 American College of Rheumatology recommendations.\n9. Any medical or social circumstance making trial participation and\u002For TARPEYO® treatment unsuitable, as assessed by the Investigator.\n10. Participants with clinically significant infections that put the participant at risk, at the discretion of the Investigator.\n11. Participants unwilling or unable to meet the requirements of the protocol.\n12. Intake of another investigational drug during trial, or during the preceding 9-monthcommercial TARPEYO® treatment period.\n13. Females who are pregnant, breastfeeding, or plan to become pregnant in the trial period.\n14. Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4",{"count":383,"type":21},60,[385],"PHASE4","The goal of this clinical trial is to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in real-world clinical practice. The main question it aims to answer is:\n\nIs there a treatment benefit of TARPEYO® 16 mg QD extended use?\n\nParticipants will\n\n* take part in this study for about 19 months\n* Have urine tests done\n* Have blood samples taken\n* Have physical examinations done",[27],[389,66,390,391,392],"TARPEYO®","urine protein-to-creatinine","ESRD","Nefecon","2026-02-03",{"date":395,"type":43},"2026-02-05",{"date":397,"type":43},"2024-12-17",{"date":399,"type":21},"2027-11",{"name":401,"class":50},"Calliditas Therapeutics AB",38,{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":409,"phases":4,"briefSummary":410,"conditions":411,"keywords":412,"overallStatus":416,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":420,"locationsCount":4},"100617512","managed-access-programs-for-exv811-atrasentan-100617512","NCT07319585","Managed Access Programs for EXV811, Atrasentan","Inclusion Criteria:\n\n1. An independent request was received from a licensed physician.\n2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.\n3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.\n4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.\n5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).\n6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.\n7. Managed Access provision is allowed per local laws\u002Fregulations.","EXPANDED_ACCESS","The purpose of this registration is to list Managed Access Programs (MAPs) related to EXV811, Atrasentan",[27],[413,414,27,415,126],"MAP","Managed Access Program","EXV811","AVAILABLE","2026-01-20",{"date":419,"type":43},"2026-01-22",{"name":135,"class":50},{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":428,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":78},"100579907","phase-2-study-of-cm313-in-subject-with-iga-nephropathy-100579907","NCT06830395","Study of CM313 in Subject With IgA Nephropathy","A Phase II Clinical Study to Evaluate the Safety and Efficacy of CM313 (SC) Injection in Subjects With Primary IgA Nephropathy","Inclusion Criteria:\n\n* Able to comprehend the research study and voluntarily signing the informed consent form (ICF).\n* Renal biopsy report supporting diagnosis of primary IgAN within 8 years prior to the screening visit.\n* Estimated Glomerular Filtration Rate (eGFR) (using the Chronic Kidney Disease Epidemiology Collaboration formula) ≥ 30 mL\u002Fmin\u002F1.73 (m\\*m) at screening and baseline.\n* Prior to the baseline visit, all subjects must have received standard care treatment, including good blood pressure control and a stable treatment of a maximum recommended or maximum tolerated dose of angiotensin-converting enzyme inhibitors(ACEI) or Angiotensin receptor blocker(ARB) for at least 12 weeks.\n* 24-hour urinary protein-to-creatinine ratio (24h-UPCR) ≥ 0.75 g\u002Fg or 24-hour urinary protein excretion (24h-UPE) ≥ 1 g\u002Fd during the screening and baseline periods.\n\nExclusion Criteria:\n\n* Secondary IgAN judged by the investigator: Secondary IgAN may be associated with Henoch-Schonlein purpura, hepatic cirrhosis, coeliac disease, human immunodeficiency virus (HIV) infection, dermatitis herpetiformis, seronegative arthritis, small cell carcinoma, lymphoma, disseminated tuberculosis, obliterative bronchiolitis, inflammatory bowel disease, familial Mediterranean fever, etc.\n* Known allergy to monoclonal antibody drugs or to the excipients of CM313.\n* Presence of rapidly progressive glomerulonephritis (RPGN), defined as 50% decline in eGFR within 3 months prior to randomization and\u002For crescent formation in more than 50% of glomeruli in a renal pathological specimen.\n* Confirmed acute kidney injury (AKI) within 4 weeks prior to randomization.\n* Vaccination of any live vaccine within 30 days prior to dosing or planned vaccination during the study period.\n* History of transplantation (any solid organ transplant, including renal transplant, bone marrow transplant, etc.) or plan to undergo renal transplantation during the study.\n* History of severe recurrent or chronic infection.\n* Malignant tumor within 5 years prior to screening (except for completely cured cervix carcinoma in situ and non-skin squamous cell carcinoma metastatic or basal cell carcinoma).",{"count":429,"type":21},106,[24],"This study is divided into two parts (Part A and Part B). This study aims to evaluate the safety and efficacy of CM313 in subjects with primary Immunoglobulin A nephropathy(IgAN), while also observing its Pharmacokinetics(PK) characteristics, Pharmacokinetics(PD) effects, and immunogenicity.",[27],"2025-09-15",{"date":435,"type":43},"2025-09-19",{"date":437,"type":21},"2025-09",{"date":439,"type":21},"2028-08",{"name":441,"class":50},"Keymed Biosciences Co.Ltd",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":267,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":78},"100595318","phase-4-nefecon-and-ambrisentan-in-iga-nephropathy-100595318","NCT07030894","Nefecon and Ambrisentan in IgA Nephropathy","A Prospective, Single-Arm Clinical Study of Budesonide in Combination With Ambrisentan for the Treatment of Patients With IgA Nephropathy","BAIN","Inclusion Criteria:\n\n* Diagnosed with IgA nephropathy by pathological biopsy within 4 years;\n* Age between 18 and 70 years old;\n* 0.5g\u002F24h ≤ 24-hour urinary protein;\n* The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula satisfies: eGFR ≥ 30 mL\u002Fmin\u002F1.73 ㎡\n\nExclusion Criteria:\n\n* Exclude special pathological or clinical kidney disease types such as crescentic glomerulonephritis (pathological diagnosis\\>50%), minimal change nephropathy with IgA deposition, etc;\n* Exclude secondary IgA nephropathy, including allergic purpura, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, viral hepatitis, cirrhosis, rheumatoid arthritis, and mixed connective tissue disease;\n* Select patients who have experienced any of the following cardiovascular events within the previous 12 weeks: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association class II or above heart failure, stroke, etc;\n* Within 12 weeks prior to the first medication, systemic use (excluding local and nasal inhalation use) of immunosuppressants, including but not limited to glucocorticoids, cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, rituximab, Tripterygium wilfordii, etc; Have used an endothelin receptor antagonist within 12 weeks prior to the first medication;\n* Active tuberculosis patients and untreated latent tuberculosis patients;\n* Patients with active hepatitis or latent hepatitis B (patients with HBcAb positive and HBV DNA positive); According to the results of the five hepatitis B tests, patients with HBsAg positivity should be excluded; Patients who are HBsAg negative but HBcAb positive, regardless of whether HBsAb is positive or negative, need to be tested for HBV-DNA to determine their condition: if HBV-DNA is positive, the patient needs to be excluded; If HBV-DNA is negative, patients can participate in the trial;\n* History of immunodeficiency diseases or positive HIV test results (enzyme-linked immunosorbent assay and protein immunoblotting);\n* Patients diagnosed with malignant tumors within the past 5 years, except for treated basal cell carcinoma of the skin, effectively resected squamous cell carcinoma of the skin, colon polyps, or cervical cancer in situ;\n* Patients undergoing kidney transplantation;\n* Pregnant women, lactating women, and men or women with fertility plans during the trial period;\n* For individuals allergic to human derived biological products;\n* Patients who have received any clinical trial medication within 4 weeks prior to their first use;\n* Participants deemed unsuitable by researchers.",{"count":451,"type":21},129,[385],"Application of Budesonide in Combination with Ambrisentan in the treatment of IgA nephropathy with progression ESKD risk (24-hour urinary protein ≥ 0.5g\u002F24h), observing the degree and safety of reducing urinary protein and delaying eGFR progression, and observing changes in serum Gd-IgA1 levels",[27,455,37],"Chronic Kidney Disease",[37,27,457,458,459],"Budesonide","Ambrisentan","Single-arm trial","2025-09-09",{"date":433,"type":43},{"date":463,"type":43},"2025-09-01",{"date":465,"type":21},"2026-12-31",{"name":467,"class":77},"The First Hospital of Jilin University",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":232,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":484,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":500},"100568066","phase-4-which-of-the-commonly-available-and-approved-drugs-in-addition-to-standard-of-care-can-significantly-improve-the-slope-of-estimated-glomerular-filtration-rate-at-two-years-when-compared-to-standard-of-care-alone-in-south-asian-kidney-biopsy-proven-adult-18-years-primary-iga-nephropathy-100568066","NCT06676384","Which of the Commonly Available and Approved Drugs in Addition to Standard of Care Can Significantly Improve the Slope of Estimated Glomerular Filtration Rate at Two Years When Compared to Standard of Care Alone in South-Asian Kidney Biopsy-proven Adult (≥18 Years) Primary IgA Nephropathy?","Randomized Embedded Adaptive Platform Clinical Trial in South Asian Kidney Biopsy-Proven Primary IgA Nephropathy: Multi-center, Multi-arm and Multi-stage","IA-GRACE-IgANT","Inclusion Criteria:\n\n1. Must be able to provide a written informed consent form, which must be obtained before the initiation of study assessments.\n2. Adults between 18-65 years of age.\n3. Males or Females.\n4. Diagnosis of primary IgAN as demonstrated by renal biopsy of any vintage if eGFR ≥45 mL\u002Fmin\u002F1.73 m2 or within the last ten years if eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2. If diabetic, the biopsy vintage should be less than five years.\n5. eGFR ≥20 mL\u002Fmin\u002F1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n6. Total urine protein excretion ≥1 g per 24-hour or UPCR ≥ 0.75 g\u002Fg from an adequately measured 24-hour urine sample (24HUP) during the Screening Period.\n7. Patient on the maximum labelled or tolerated dose of ACEi or ARB AND 10mg\u002Fd of Dapagliflozin (SGLT2i) for at least 12 weeks at screening and from screening to study Day 1.\n8. Systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤90 mmHg at randomisation. Other anti-hypertensives can be optimised during the screening period to achieve the BP goal.\n9. A female is eligible if she is not pregnant and consents to avoid pregnancy during the study duration.\n\nExclusion Criteria:\n\n1. IgAN secondary to another condition (e.g., liver cirrhosis) or other causes of mesangial IgA deposition such as systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis, etc. IgA vasculitis (i.e., Henoch-Schonlein purpura) with biopsy-proven mesangial IgA deposition and no active skin vasculitis for the last year can be included.\n2. Evidence of nephrotic syndrome at screening (serum albumin \\\u003C3g\u002FdL AND UPCR \\>3.5 g\u002Fg).\n3. Evidence of rapidly progressive glomerulonephritis defined as loss of ≥ 50% of eGFR in three months before screening.\n4. Concomitant kidney disease in addition to IgAN in kidney biopsy (e.g., diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis).\n5. Female patients planning pregnancy.\n6. Concomitant co-morbidities like systemic autoimmune disorders, chronic active infections like tuberculosis, hepatitis B, hepatitis C and human immunodeficiency virus infection, chronic liver disease, and chronic obstructive pulmonary disease.\n7. Renal or other organ transplantation before, or expected during, the study, except for corneal transplants.\n8. Morbid obesity defined as BMI ≥ 40 kg\u002Fm2 at screening.\n9. Uncontrolled diabetes as defined by HbA1c \\> 8% at screening.\n10. History or diagnosis of demyelinating diseases such as multiple sclerosis or optic neuritis.\n11. Prohibited medications:\n\n    * Participants who received oral steroids over two weeks within 12 weeks before screening.\n    * Immunosuppressive medications (e.g., MMF, azathioprine, cyclophosphamide, hydroxychloroquine) for treating IgAN within 12 weeks before screening.\n    * Use of B-cell-directed biologic therapies, including belimumab, rituximab, and ocrelizumab, within six months before screening.\n    * Use of other biologics (e.g., anti-TNF, abatacept, anti-IL-6) and investigational biologics within the last four weeks or five half-lives, whichever is longer, before the screening.\n    * Use of traditional medications and\u002For Ayurvedic medications within 12 weeks before screening.\n    * Use of endothelin receptor antagonists\u002F oral spironolactone or oral finerenone\u002F GLP-1 agonists\u002F hydroxychloroquine within 12 weeks before screening.\n12. Patients with a history of unstable angina, Class III and IV congestive heart failure, and clinically significant arrhythmia, as judged by the Investigator.\n13. Active clinically significant viral, bacterial, or fungal infection or any major episode of infection requiring hospitalisation or treatment with parenteral anti-infectives within four weeks before or during the Screening Visit.\n14. History of malignancy within the past five years before Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ, with no evidence of recurrence).\n15. Known hypersensitivity to any of the interventions.\n16. Major surgery within six weeks before the Screening Visit.\n17. Clinically significant history of alcohol or drug abuse in the one year before the Screening Visit as per the Investigator's opinion.\n18. Unwillingness or lack of capacity to follow all study procedures.",{"count":477,"type":21},585,[385],"Global Burden of Diseases ranks chronic kidney disease (CKD) as the 12th leading cause of death, with an estimated 20% increase from 2010 to 2019. India is the most populous country in South Asia, with one-fourth of the global population. CKD prevalence has reached epidemic proportions in South Asia, with 1 in 7 adults affected by it. Glomerular diseases are the most common cause of CKD after diabetes and hypertension. IgAN is the most common primary glomerular disease in adults. In the Caucasian and East Asian populations, IgAN results in end-stage kidney disease (ESKD) in 15-20% of patients within 15-20 years after the first clinical presentation.\n\nOur first prospective observational (GRACE-IgANI) cohort since 2015 showed that South Asians have severe and progressive IgAN, with 39% having a rapid fall in eGFR, 25% having non-remission of proteinuria, and 36% reaching an adverse kidney outcome at three years. Our group has shown that South Asian ethnicity is associated with a severe phenotype, rapid progression, and significant ethnic differences in biomarkers.\n\nOver the last few years, newer anti-proteinuric agents and immunomodulatory drugs have either been approved by the FDA or are in the late phases of clinical trials for various proteinuric kidney diseases. The results of the STOP-IgAN and the recent TESTING trial have shown that the short-term beneficial effects of steroids on proteinuria and eGFR slope at six months wane over time, and there is a need for effective longer-term agents. The KDIGO guidelines development body on glomerular diseases has actively advocated enrolling patients prospectively in 'Clinical Trials'.\n\nPlatform trials are Multi-Arm and Multi-Stage (MAMS) randomised CTs comparing multiple parallel interventional groups against standardised common control groups with central coordination. It allows new interventions to be added, the control group to be updated throughout the trial, and the use of prespecified interim analysis plans for statistical efficiencies. Interventional groups can be introduced after the trial has started based on pre-specified criteria, and futile interventions may be stopped based on pre-specified interim analyses and trial-stopping rules.\n\nThis is a randomised controlled single-blind (outcome assessor) Platform trial, Multi-Arm and Multi-Stage. There is a single overarching protocol called a Master protocol. The master protocol, the common concurrent control arm for multiple interventions,the within-trial adaptations, the pre-specified interim analyses, and the pragmatic nature ensure greater acceptability and allow key trial characteristics to evolve. The overall strategy of the study relies strongly on pragmatic 'real world clinical situations' faced by practising nephrologists when treating adult patients with kidney biopsy-proven primary IgAN in South Asia. It will establish the 'GRACE Clinical Trial Network'.\n\nThe overarching trial hypothesis is that commonly available and approved generic drugs (low-dose oral prednisolone, gut-directed budesonide, mycophenolate mofetil, and hydroxychloroquine) in addition to Standard of Care (SoC), which is the maximal labelled or tolerated dose of renin-angiotensin system blockers (ACEi\u002F ARB) and a steady dose of sodium-glucose cotransporter 2 inhibitors (SGLT2i) can significantly improve the kidney outcomes at two years when compared to Standard of Care (SoC) alone in South Asian kidney biopsy-proven adult (≥18 years) primary IgAN who on follow-up remain at high risk of progression defined as UPCR ≥0.75g\u002Fg and baseline eGFR ≥20ml\u002Fmin\u002F1.73m2 despite good BP control. SoC is defined as a maximal labelled or tolerated dose of ACEi\u002F ARB and a steady dose of SGLT2i with a goal BP \\\u003C140\u002F90 mmHg for at least three months.",[27,481,482,483],"Renal Insufficiency, Chronic","IgA Vasculitis","IGA Glomerulonephritis",[485,486,487,27,488,29,482,489,490],"Platform Trial","Randomised Embedded Trial","MAMS Trial","Chronic kidney disease","Single blind","Treatment","2025-07-10",{"date":493,"type":43},"2025-07-14",{"date":495,"type":43},"2025-02-15",{"date":497,"type":21},"2029-08",{"name":499,"class":77},"Christian Medical College, Vellore, India",12,{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":17,"minAge":144,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":520},"100572996","phase-2-trial-of-the-impact-of-sibeprenlimab-on-immunoglobulin-a-nephropathy-kidney-tissue-100572996","NCT06740526","Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue","A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy","Inclusion Criteria:\n\n1. Participants must be at least 16 years of age or older at the time of signing the informed consent\u002Fassent.\n2. Source-verified kidney biopsy confirmed diagnosis of IgAN.\n3. Participant has estimated glomerular filtration rate (eGFR) \\> 45 mL\u002Fmin\u002F1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration \\[CKD EPI\\] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 \\[CKiD U25\\] eGFR equation for those younger than 18 years)\n\nExclusion Criteria:\n\n1. Participants who are breast-feeding and\u002For who have a positive pregnancy test result prior to receiving sibeprenlimab.\n2. Participant has coexisting chronic kidney disease, other than IgAN.\n3. Participant has a serum IgG value \\\u003C600 mg\u002FdL at screening.\n4. Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:\n\n   topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).\n5. Participant has uncontrolled hypertension (defined as systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg).\n6. Participants who would be likely to require prohibited concomitant therapy during the trial.",{"count":7,"type":21},[24],"This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.",[27],"2025-04-04",{"date":514,"type":43},"2025-04-06",{"date":516,"type":43},"2024-11-19",{"date":518,"type":21},"2029-04-17",{"name":102,"class":50},5,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":527,"sex":17,"minAge":144,"maxAge":232,"enrollmentInfo":528,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":530,"conditions":531,"keywords":532,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":520},"100453923","correlation-of-microbiome-and-metabonomics-with-iga-nephropathy-100453923","NCT05190848","Correlation of Microbiome and Metabonomics With IgA Nephropathy","Inclusion Criteria:\n\n* (1) Pathological changes of IgAN were confirmed by renal biopsy (2) Age ≥16 years (3) IgA deposition caused by secondary factors such as non-purpura glomerulonephritis, liver cirrhosis, SLE, HIV infection and hepatitis B virus associated nephritis (4) No antibiotics and\u002For functional foods (probiotics and\u002For prebiotics) for at least one month prior to sampling (5) No hormone or immunosuppressant treatment in the six months prior to sampling (6) No significant changes in diet or medication for at least one month (7) No other immune or autoimmune diseases, such as systemic lupus erythematosus (8) Signed informed consent\n\nExclusion Criteria:\n\n1. Type I or type II diabetes\n2. Pregnancy and menstrual period\n3. Mental illness and inability to assess follow-up\n4. Medically diagnosed intestinal diseases such as irritable bowel syndrome and inflammatory bowel disease\n5. Viral hepatitis or other infectious diseases\n6. One month before specimen collection, use laxatives including but not limited to polyethylene glycol electrolyte dispersant, enema and other laxatives",true,{"count":529,"type":21},600,"IgAN is the most prevalent primary glomerulonephritis in China, is characterized by the deposition of IgA1 (particularly, galactose-deficient IgA1) in the glomerular mesangium. Galactosedeficient IgA1, supposed to be produced by Peyer patches in the mucosa-associated lymphoid tissue (MALT), is triggered by exposure to commensal or pathogenic bacteria, involved in the initial step in the pathogenesis of IgAN. Similar to intestinal flora, a disruption in oral flora is closely associated with the occurrence of many malignant tumors and autoimmune diseases. The relationship between oral and throat microflora and the occurrence of IgAN is unclear at present. The aim of the present study was to develop a preliminary model based on mucosa -specific microbes and clinical indicators to facilitate the early diagnosis of IgAN and obtain insights into its treatment.",[27],[533],"IgAN microbiome metabolite","2025-03-10",{"date":536,"type":43},"2025-03-12",{"date":538,"type":43},"2020-05-01",{"date":540,"type":21},"2025-12-01",{"name":542,"class":77},"Guangdong Provincial People's Hospital",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":22,"phases":552,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":234},"100575621","phase-1-a-clinical-study-of-sctc21c-in-participants-with-plasma-cell-driven-autoimmune-diseases-100575621","NCT06774664","A Clinical Study of SCTC21C in Participants With Plasma Cell-driven Autoimmune Diseases","A Randomized, Double-blind, Placebo-controlled Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTC21C in Subjects With Plasma Cell-driven Autoimmune Diseases","Inclusion Criteria:\n\n1. Age ≥18 years at the time of signing the ICF;\n2. The subject has been diagnosed with IgA nephropathy through kidney tissue biopsy;\n3. The subject has been on a stable and maximally tolerated dose of ACEI or ARB (or the maximum allowable dose according to the prescribing information) for at least 12 weeks prior to the first dose. Subjects using both ACEI and ARB simultaneously will not be accepted;\n4. The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula must be ≥30 mL\u002Fmin\u002F1.73 m²;\n5. During the screening period, the subject must have 24-hour proteinuria ≥1.0 g or a urine protein-to-creatinine ratio (UPCR) ≥0.75 g\u002Fg based on 24-hour urine protein;\n6. All male subjects or women of childbearing potential (with a negative blood pregnancy test within 7 days prior to the first dose of investigational drug) must agree to use reliable contraception together with their partner from the time of signing the ICF until 5 months after the last dose of the study drug;\n7. Understand the study procedures and voluntarily sign the informed consent form in writing.\n\nExclusion Criteria:\n\n1. IgA nephropathy secondary to other diseases;\n2. Any kidney disease with special pathological or clinical types, such as nephrotic syndrome, crescentic glomerulonephritis, etc.;\n3. Use of systemic corticosteroids within the 3 months prior to baseline or expected use during the study period;\n4. Use of systemic immunosuppressive drugs within the 3 months prior to baseline or expected use during the study period;\n5. Use of other B-cell-targeting biologics or unapproved investigational biologics within the 6 months prior to baseline;\n6. Patients who have experienced any of the following cardiovascular events within 24 weeks prior to baseline: myocardial infarction, unstable angina, ventricular arrhythmias, heart failure with NYHA class II or higher, stroke, etc.;\n7. A history of solid organ or hematopoietic stem cell or bone marrow transplantation, or expected to undergo a transplant procedure during the treatment period with the investigational drug；\n8. Currently undergoing hemodialysis or peritoneal dialysis, or expected to require hemodialysis or peritoneal dialysis during the treatment period with the investigational drug;\n9. Any symptoms or signs within 30 days prior to baseline indicating an active infection (excluding the common cold), or requiring systemic anti-infective treatment, or being at high risk for infection;\n10. Positive viral serology, including HIV, HCV, and HBV, etc.; Hepatitis B patients: active hepatitis or severe liver disease;\n11. Currently or within the past 5 years has had malignant tumors, except for fully treated skin basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, or cervical intraepithelial neoplasia;\n12. Known allergy to the active ingredient or excipients of the investigational drug.",{"count":551,"type":21},99,[236,24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in subjects with plasma cell-driven autoimmune diseases",[27],"2025-01-08",{"date":557,"type":43},"2025-01-14",{"date":559,"type":21},"2025-01",{"date":561,"type":21},"2029-03",{"name":563,"class":50},"Sinocelltech Ltd.",{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":22,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"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":500,"type":21},[177],"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",[27,575],"Membranous Nephropathy","2024-11-25",{"date":578,"type":43},"2024-11-26",{"date":580,"type":21},"2024-12-13",{"date":582,"type":21},"2026-12-20",{"name":584,"class":50},"Beijing Immunochina Medical Science & Technology Co., Ltd.",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":594,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":78},"100498806","phase-2-clinical-study-of-cm338-in-the-treatment-of-immunoglobulin-a-nephropathy-100498806","NCT05775042","Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy","A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy","Inclusion Criteria:\n\n* Male or female aged 18-75.\n* Understand the nature of the study and sign the Informed Consent Form voluntarily.\n* Take effective contraception measures throughout the study period.\n\nExclusion Criteria:\n\n* Used other investigational drugs within 30 days before the first study administration.\n* With previous history of Human immunodeficiency virus(HIV) infection.\n* Treponema pallidum antibody positive in screening period.\n* May have active Mycobacterium tuberculosis infection.\n* Major surgery is planned during the study.\n* Other reasons the investigator believes that the subject is not suitable to participate in this study.",{"count":593,"type":21},70,[24],"This study is a multicenter, randomized phase II clinical study to evaluate Efficacy and safety, while observing pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of CM338 in subjects with Immunoglobulin A(IgA) nephropathy.",[27],"2024-10-14",{"date":599,"type":43},"2024-10-15",{"date":601,"type":43},"2023-05-08",{"date":603,"type":21},"2027-06-30",{"name":441,"class":50},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":527,"sex":17,"minAge":18,"maxAge":612,"enrollmentInfo":613,"targetDuration":4,"studyType":22,"phases":615,"briefSummary":616,"conditions":617,"keywords":619,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":78},"100511683","phase-1-a-first-in-human-study-to-evaluate-safety-tolerability-pharmacology-of-hs-10390-in-healthy-subjects-100511683","NCT05942625","A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Studyto Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects","Inclusion Criteria:\n\n* Healthy male or female subjects between the ages of 18-45 years\n* Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing\n* Have signed the informed consent form approved by the IRB\n\nExclusion Criteria:\n\n* History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and\u002For excretion of the studydrug, determined by the investigator\n* Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, AIDS and syphilis\n* Have a history of or current allergic disease\n* Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse\n* Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine\n* Clinically significant abnormal physical examination, vital signs, clinical laboratory values,ECGs or imaging tests\n* Pregnant or breastfeeding female subjects","45 Years",{"count":614,"type":21},84,[236],"The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.",[27,618],"Focal Segmental Glomerulosclerosis",[620,621,622,623,624],"HS-10390","Safety","Tolerability","Pharmacokinetics","Pharmacodynamics","2024-10-07",{"date":627,"type":43},"2024-10-09",{"date":629,"type":43},"2023-05-23",{"date":631,"type":21},"2024-12-30",{"name":633,"class":50},"Hansoh BioMedical R&D Company",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":22,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":4},"100560679","phase-3-effect-of-finerenone-in-iga-nephropathy-100560679","NCT06580288","Effect of Finerenone in IgA Nephropathy","A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Finerenone in the Treatment of IgA Nephropathy","FIGHT","Inclusion Criteria:\n\n* Kidney biopsy confirmed IgA nephropathy within 2 years, with secondary IgA nephropathy excluded;\n* Age ≥ 18 years;\n* Maximum tolerated dose of RAS inhibitors for more than 3 months, with urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg and ≤ 3500 mg\u002Fg; V1 laboratory test showing urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg and ≤ 3500 mg\u002Fg. After maximum tolerated dose of RAS inhibitors or ARB, V2 urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg and ≤ 3500 mg\u002Fg;\n* eGFR calculated by EPI ≥ 30 ml\u002Fmin\u002F1.73 m²;\n* Serum potassium level ≤ 4.8 mmol\u002FL;\n* SBP ≤ 150 mmHg, DBP ≤ 110 mmHg;\n* LVEF \\> 40%;\n* Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* There are clear indications for the use of immunosuppressive therapy, such as: nephrotic syndrome (urine protein greater than 3.5 g\u002Fd, blood albumin less than 30 g\u002FL), pathological minimal change disease combined with IgA nephropathy; the proportion of crescents in kidney biopsy is ≥ 50%.\n* Any existing life-threatening condition with a life expectancy of less than 2 years;\n* Active infection, HBV infection, or active lesions (nodules, cavities, or tuberculomas);\n* AKI causing renal dysfunction;\n* Use of steroids\u002Fimmunosuppressive drugs within the past 3 months;\n* History of malignant tumors, regardless of treatment status or evidence of local recurrence or metastasis;\n* Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of the investigational drug;\n* History of drug or alcohol abuse within the past 12 months;\n* History of drug allergies or contraindications;\n* Previous noncompliance or unwillingness to follow the study protocol;\n* Any condition that may affect safety or efficacy;\n* History of kidney transplantation or currently receiving immunosuppressive treatment;\n* Pregnant or breastfeeding women;\n* Obese patients with a BMI \\> 35.",{"count":643,"type":21},120,[91],"The aim of this trial is to conduct a randomized, multicenter, placebo-controlled, double-blind clinical trial to determine the safety and efficacy of Finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.\n\nThe primary endpoint event was the change in urinary albumin\u002Fcreatinine ratio between the two groups at 12 months of treatment.",[27],"2024-08-28",{"date":649,"type":43},"2024-08-30",{"date":651,"type":21},"2024-10-08",{"date":653,"type":21},"2026-10-08",{"name":655,"class":77},"Zhejiang University","IGA Nephropathy"]