[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunoglobulin-a-nephropathy-igan\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunoglobulin-a-nephropathy-igan":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,73,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100587974","phase-3-a-study-to-learn-about-the-effects-of-felzartamab-infusions-on-adults-with-immunoglobulin-a-nephropathy-igan-100587974",false,"NCT06935357","A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)","PREVAIL","Key Inclusion Criteria:\n\n* Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, an IgAN diagnostic biopsy within the past 24 months prior to signing the ICF.\n* An eGFR ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and \\\u003C 30 mL\u002Fmin\u002F1.73 m\\^2 is acceptable for the cohorts 3 and 4.\n* Proteinuria of ≥ 1.0 gram per day (g\u002Fday) or UPCR ≥0.8 gram per gram (g\u002Fg) as assessed by an adequate 24-hour urine collection.\n* Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is); endothelin receptor antagonists (ERAs) or dual endothelin angiotensin receptor antagonist (DEARAs) approved for the treatment of IgAN; and\u002For mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using a DEARA (e.g., sparsentan) will not be permitted to use simultaneous ACEI or ARB medication.\n\nKey Exclusion Criteria:\n\n* Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator.\n* History of rapidly progressive variant of IgAN, defined as eGFR loss by \\> 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors.\n* IgAN-(MCD) variant.\n* Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.\n* Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) \\> 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy).\n* Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants.\n* Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic glucocorticoid exposure (\\> 7.5 milligrams per day \\[mg\u002Fd\\] prednisone-equivalent for indications other than IgAN or any dose if given for the treatment of IgAN) within 4 months prior to Screening. Use of hydroxychloroquine in Mainland China is allowed if the candidate has been on this for at least 6 months prior to Screening with a stable dose for at least 12 weeks prior to Screening. If a potential participant requires systemic glucocorticoids at any dose for IgAN during Screening, this will result in a screen fail. If a potential participant requires systemic glucocorticoids \\> 7.5 mg\u002Fday prednisone-equivalent for indications other than IgAN during Screening, this will result in a screen fail.\n* Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to Screening may be eligible.\n* Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or non-prophylactic treatment with IV anti-infectives (antibacterials, antiviral or antifungals). Participants with a history of opportunistic infections are excluded.\n* Hypogammaglobulinemia: serum Immunoglobin G (IgG) \\\u003C 6.0 gram per litre (g\u002FL), at Screening.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},454,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys.\n\nThe main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is:\n\n• How much does the amount of protein in the urine change from the start of the study to Week 36?\n\nResearchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body.\n\nThe study will be done as follows:\n\n* Participants will be screened to check if they can join the study.\n* Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.\n* Neither the researchers nor the participants will know what the participants will receive.\n* Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks.\n* Afterwards, participants will enter a follow-up period which will last 80 weeks.\n* In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.",[27],"Immunoglobulin A Nephropathy (IgAN)",[29],"Felzartamab","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2025-05-08",{"date":38,"type":21},"2029-06-05",{"name":40,"class":41},"Biogen","INDUSTRY",246,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100633085","phase-2-chinese-adults-with-kidney-disease-100633085","NCT07522099","Chinese Adults With Kidney Disease","A Phase 2 Study to Assess ADX-038 in Chinese Adults With Complement-Mediated Kidney Disease","Inclusion Criteria:\n\n* Mean eGFR greater than or equal to 30 mL\u002Fmin\u002F1.73m2\n* Clinical evidence of active kidney disease\n* Treated with supportive care including an ACE inhibitor or ARB if applicable\n* Willing to receive required vaccinations\n* Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy\n\nExclusion Criteria:\n\n* Previous kidney transplant or major solid organ transplant\n* Required renal replacement therapy for more than 72 hours\n* Rapidly progressive glomerular nephritis or acute kidney injury\n* History of recurrent invasive infection\n* Current or previous use of C5 or CFB inhibitors (such as eculizumab, ravulizumab or iptacopan)\n* Active TB, HIV or other systemic infection\n* Abnormal liver function",{"count":51,"type":21},30,[53],"PHASE2","This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).",[27,56,57],"Complement 3 Glomerulopathy (C3G)","IC-MPGN",[59,60,57,61,62],"IgAN","C3G","complement mediated kidney diseases","IgA Nephropathy","2026-06-23",{"date":65,"type":34},"2026-06-25",{"date":67,"type":34},"2026-05-21",{"date":69,"type":21},"2029-01-21",{"name":71,"class":41},"ADARx Pharmaceuticals, Inc.",10,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100604237","phase-2-a-study-to-assess-the-effects-of-zigakibart-on-iga-nephropathy-100604237","NCT07146906","A Study to Assess the Effects of Zigakibart on IgA Nephropathy.","An Open-label, Multicenter Study to Assess the Effect of Zigakibart Treatment on Histologic, Circulating, and Excreted Markers of Kidney Disease and Dysfunction in Adult Patients With IgA Nephropathy.","SHIFT","Inclusion Criteria:\n\n* Primary IgAN, confirmed by kidney biopsy, within 5 years prior to Screening\n* eGFR ≥45 mL\u002Fmin\u002F1.73 m2, based on the 2021 CKD-EPI equation, at Screening\n* Persistent proteinuria, defined as either\n\n  * Total Urine Protein ≥0.5 g\u002Fday or UPCR ≥0.5 g\u002Fg in a 24-hour urine collection, at Screening, despite maximally tolerated dose or poorly tolerated supportive therapy or\n  * IgAN diagnosis \\\u003C6 months prior to Screening with Total Urine Protein \\>1.5 g\u002Fday or UPCR \\>1.5 g\u002Fg in a 24-hour urine collection, at the time of clinical presentation or diagnosis\n* Body weight ≥45 kg and body mass index (BMI) ≤35.0 kg\u002Fm2, at Screening\n\nExclusion Criteria:\n\n* Secondary forms of IgAN, as determined by the Investigator, diagnosis of IgA vasculitis, or any other nephropathy or chronic urinary tract disorder\n* Total IgG \\\u003C6.0 g\u002FL at screening\n* Any chronic urinary tract disorder, including but not limited to retention, incontinence, and\u002For recurrent urinary tract infections\n* An average systolic blood pressure \\>150 mmHg or average diastolic blood pressure \\>90 mmHg based on three measurements at Screening\n* Treatment with complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors or corticosteroids, immunosuppressive or immunomodulatory agents within 12 months prior to screening\n* Acute kidney injury (AKI), defined by AKI network criteria, within 4 weeks prior to screening\n* Current treatment with anti-APRIL monoclonal antibodies or dual APRIL\u002FBAFF inhibitors or past treatment of the same at any time for \\>3 consecutive months prior to screening\n* Planned initiation of, or recently (within 24 weeks) initiated, treatment with glucagon-like peptide-1 agonists at screening\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":83,"type":21},32,[53],"The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.",[27],[88,89,90,79,91,59,92,93,94,95],"zigakibart","FUB523","anit-APRIL","IgA nephropathy","proteinuria","kidney","biopsy","adults","2026-06-19",{"date":63,"type":34},{"date":99,"type":34},"2026-03-26",{"date":101,"type":21},"2030-10-18",{"name":103,"class":41},"Novartis Pharmaceuticals",26,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100629435","phase-2-efficacy-and-safety-study-of-hs-10542-for-iga-nephropathy-100629435","NCT07474636","Efficacy and Safety Study of HS-10542 for IgA Nephropathy","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of HS-10542 Capsules in Primary Immunoglobulin A (IgA) Nephropathy","HS-10542","Inclusion Criteria:\n\n1. Participant is a male or female≥18 years and≤74 years of age at the time of signing the informed consent.\n2. Body weight≥35kg, BMI\\\u003C37.5kg\u002Fm2.\n3. Primary IgA nephropathy was confirmed by renal biopsy within 8 years.\n4. 24-hour urine protein excretion≥1.0g\u002F24h, or UPCR≥0.8g\u002Fg at screening and prior to randomization.\n5. eGFR≥30 ml\u002Fmin\u002F1.73m2 at screening and prior to randomization；\n6. A fertile female participant or a male participant whose partner is a fertile female, who has not had a fertility, sperm\u002Fegg donation plan and voluntarily takes highly effective contraceptive measures (including the partner).\n7. All participants received RAS blocker treatment at least for 12 weeks, or demonstrated intolerance to RAS blockers, but has received SGLT2 inhibitors, endothelin receptor antagonists, or a mineralocorticoid receptor antagonist for at least 12 weeks, and have achieved the maximum recommended dose according to the product label or the maximum tolerated dose with stable dosing for at least 4 weeks prior to randomization.\n8. Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose.\n9. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.\n\nExclusion Criteria:\n\n1. Participants with a history of severe allergies to drugs, food or the environment, or allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;\n2. Participant has secondary forms of IgAN as defined by investigator (eg, IgA vasculitis nephritis, SLE) or participant has nephrotic syndrome (defined as proteinuria\\>3.5 g\u002Fday and serum albumin\\\u003C3.0 g\u002FdL, with or without edema);\n3. IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;\n4. Patients with concomitant immunodeficiency disorders; or those with other systemic diseases assessed by the investigator as potentially causing proteinuria (e.g., diabetic nephropathy, autoimmune diseases, ANCA-associated vasculitis, etc.);\n5. Any organ transplant recipient, including those who have undergone solid organ transplants, bone marrow transplants and haematopoietic stem cell transplants.\n6. Participants with a medical history of invasive infections caused by capsulated bacteria, including Neisseria meningitidis and Streptococcus pneumoniae;\n7. Participants with chronic recurrent infections within 1 year prior to screening, such as liver abscess and pyelonephritis; Or participants with active infection who requiring intravenous antibiotic therapy within 2 weeks prior to randomization;\n8. Participants have a history of malignancy (except of radical excision of basal cell or squamous cell skin cancer, or cervical carcinoma in situ.), Participants with prior malignancy who have been documented to be cancer-free for≥5 years may be enrolled;\n9. Participants with a history of severe trauma or major surgery within 12 weeks prior to screening, or who plan to undergo surgery during the study period;\n10. Participants with a history of blood donation or a history of severe blood loss (≥400 mL blood loss) within 12 weeks prior to screening, or who have received blood transfusions within 12 weeks prior to screening;\n11. Participants had received systemic glucocorticoid therapy, immunosuppressive agents (e.g. mycophenolate mofetil or calcineurin inhibitors), Chinese patent medicines with immunosuppressive properties (e.g. Tripterygium wilfordii tablets), or renin inhibitors within 12 weeks of randomisation. Alternatively, they were assessed by the investigator as potentially requiring such treatments during the study period.\n12. Participants had received treatment with biologics (e.g. telitacicept, atacicept, povetacicept, sibeprenlimab, CD38 monoclonal antibodies), or with budesonide enteric capsules (NEFECON) or cytokine inhibitors, as well as other products related to the complement pathway (e.g. eculizumab, ravulizumab and avacopan), which were not included in the investigational drug of this study within 6 months prior to randomisation, or participants had received iptacopan within 12 weeks prior to randomization;\n13. Participants have a history of gastrointestinal surgery that may significantly affect the absorption, distribution, metabolism or excretion of drugs. Or have a history of severe gastrointestinal disease, or be experiencing symptoms of dysphagia or recurrent vomiting that cause difficulty eating or taking medication.\n14. Participants with poorly controlled severe systemic diseases at screening, including, but not limited to, severe hypertension (SBP≥180 mmHg and\u002For DBP110 mmHg), severe cardiac disease, pulmonary disease, hepatic disease or haematological disorders, which significantly increase the participant's safety risk as assessed by the investigator;\n15. Participants with a history of tuberculosis, or who have current symptoms, signs, imaging or laboratory evidence of active tuberculosis, or who have a positive IGRA tuberculosis infection screening test result (except the participants who have medical documented evidence of having received standardized preventive anti-tuberculosis treatment within the 5 years prior to screening);\n16. ALT or AST or total bilirubin levels\\>3×ULN at screening;\n17. Hb\\\u003C90 g\u002FL or PLT\\\u003C80×109\u002FL at screening;\n18. HBsAg positive; or HBsAg negative but HBcAb positive with HBV-DNA quantitative results exceeding the ULN defined by the local lab; HCV antibody positive with HCV-RNA quantitative results exceeding the ULN defined by the local lab; HIV antibody positive;\n19. HBA1C≥9.0% at screening;\n20. Participants who have participated in a clinical trial of any drug or medical device within 12 weeks prior to randomization and are expected to have residual effects of the investigational treatment (as determined by the investigator), or in any drug clinical trial within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to screening, or who participated in a clinical trial of oligonucleotide drugs within 1 year prior to randomization;\n21. Women who are pregnant or breastfeeding prior to randomization;\n22. Drug or alcohol abuse within 6 months prior to randomization;\n23. Any illness or condition that the investigator deems likely to increase the risk of the trial, affect participants adherence to the protocol or prevent them from completing it.","74 Years",{"count":115,"type":21},90,[53],"This is a multicenter, randomized, double-blind, parallel, placebo-controlled study and is being conducted to evaluate the efficacy and safety of HS-10542 capsules for primary IgA nephropathy.",[59,27,119],"Glomerular Disease",[59,121,111],"Immunoglobulin A Nephropathy","NOT_YET_RECRUITING","2026-03-11",{"date":125,"type":34},"2026-03-16",{"date":127,"type":21},"2026-03-17",{"date":129,"type":21},"2028-01-30",{"name":131,"class":41},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",1]