[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ic-mpgn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ic-mpgn":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,79,104,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053717","phase-3-study-of-efficacy-and-safety-of-iptacopan-in-participants-with-ic-mpgn-100053717",false,"NCT05755386","Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN","A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Idiopathic Immune-complex-mediated Membranoproliferative Glomerulonephritis (IC-MPGN)","APPARENT","Inclusion Criteria:\n\n* Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening).\n* Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only).\n* Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization\n* UPCR ≥ 1.0 g\u002Fg (≥ 113 mg\u002Fmmol) sampled from the first morning void urine sample at Day -75 and Day -15\n* Estimated GFR (using the chronic kidney disease \\[CKD\\]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 12 to 17 years) or measured GFR ≥ 30 ml\u002Fmin\u002F1.73m2 at screening and Day -15.\n* Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required, the vaccine should be given according to local regulations at least 2 weeks prior to the first administration of study treatment. If the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care.\n* If not previously vaccinated, or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration.\n\nExclusion Criteria:\n\n* Participants who have undergone cell or solid organ transplantation, including kidney transplantation.\n* Participants diagnosed with secondary IC-MPGN including but not limited to any of the following conditions:\n* Deposition of antigen-antibody immune complexes as a result of any chronic infections, including\n\n  * Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);\n  * Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections\n  * Protozoa\u002Fother infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis\n\nRenal deposition of immune complexes as a result of a systemic autoimmune disease:\n\n* Systemic lupus erythematosus (SLE)\n* Sjögren syndrome\n* Rheumatoid arthritis\n* Mixed connective tissue disease Deposition of monoclonal immunoglobulins because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.\n\nFibrillary glomerulonephritis\n\n* Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy.\n* Kidney biopsy showing interstitial fibrosis\u002Ftubular atrophy (IF\u002FTA) of more than 50%.\n* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or the presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.\n* A history of recurrent invasive infections caused by encapsulated organisms, e.g., Neisseria meningitidis and Streptococcus pneumoniae.\n* The use of inhibitors of complement factors (e.g., Factor B, Factor D, complement 3 (C3) inhibitors, anti-Complement 5 (C5) antibodies, C5a receptor antagonists) within 3 months or 5 half-lives prior to the Screening visit.\n* The use of immunosuppressants (except MPAs), cyclophosphamide or systemic corticosteroids at a dose \\>7.5 mg\u002Fday (or equivalent for a similar corticosteroid medication) within 90 days of study drug administration.\n* The use of MPAs is not permitted within 90 days prior to randomization in India, as per the local health authority requirement.\n* Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator.\n* Body mass index (BMI) \\>38 kg\u002Fm2 at screening and randomization. Body weight \\\u003C35 kg at screening and randomization","ALL","12 Years","60 Years",{"count":21,"type":22},106,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.",[28],"IC-MPGN",[30,28,31,32,33,34],"LNP023","iptacopan","UPCR","eGFR","proteinuria","RECRUITING","2026-07-09",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2023-10-02",{"date":43,"type":22},"2029-05-31",{"name":45,"class":46},"Novartis Pharmaceuticals","INDUSTRY",131,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"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","18 Years",{"count":57,"type":22},30,[59],"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).",[62,63,28],"Immunoglobulin A Nephropathy (IgAN)","Complement 3 Glomerulopathy (C3G)",[65,66,28,67,68],"IgAN","C3G","complement mediated kidney diseases","IgA Nephropathy","2026-06-23",{"date":71,"type":39},"2026-06-25",{"date":73,"type":39},"2026-05-21",{"date":75,"type":22},"2029-01-21",{"name":77,"class":46},"ADARx Pharmaceuticals, Inc.",10,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100592125","phase-2-phase-2-study-of-adx-038-in-complement-mediated-kidney-disease-100592125","NCT06989359","Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease","A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease","Inclusion Criteria:\n\n* Mean eGFR greater than or equal to 30 mL\u002Fmin\u002F1.73m2\n* Clinical evidence of active kidney disease\n* Treated with supportive care including an ACE inhibitor or ARB if applicable\n* Willing to receive required vaccinations\n* Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy\n\nExclusion Criteria:\n\n* Hereditary or acquired complement deficiency\n* Kidney transplant or renal replacement therapy\n* History of solid organ transplant\n* Other kidney disease\n* History of recurrent invasive infections\n* Received complement inhibitor treatments\n* Active systemic viral, bacterial, or fungal infection\n* Abnormal liver function",{"count":87,"type":22},45,[59],"This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.",[65,66,91,92,28],"Complement-mediated Kidney Disease","IgA Nephropathy (IgAN)",[68,65,66,28,94],"complement-mediated kidney disease","2026-06-12",{"date":97,"type":39},"2026-06-16",{"date":99,"type":39},"2025-08-28",{"date":101,"type":22},"2029-06",{"name":77,"class":46},29,{"id":105,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":26,"conditions":108,"keywords":109,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":114,"leadSponsor":115,"locationsCount":116},"100497295",{"count":21,"type":22},[25],[28],[30,28,31,32,33,34],"2026-05-28",{"date":112,"type":39},"2026-06-01",{"date":41,"type":39},{"date":43,"type":22},{"name":45,"class":46},130,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100576518","phase-2-a-study-of-sgb-9768-in-patients-with-complement-mediated-kidney-diseases-100576518","NCT06786338","A Study of SGB-9768 in Patients with Complement-mediated Kidney Diseases","A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SGB-9768 in Patients with Primary IgA Nephropathy, C3 Glomerulopathy, and Immune Complex-mediated Membranoproliferative Glomerulonephritis.","Inclusion Criteria:\n\n* Aged ≥18 years\n* Weight ≥40 kg, with a body mass index (BMI) between 15 and 35 kg\u002Fm²\n* Biopsy-confirmed diagnosis of primary IgA nephropathy, C3 glomerulopathy or IC-MPGN, accompanied by C3 deposition in the glomeruli.\n* Urine protein-to-creatinine ratio (UPCR) ≥0.75 g\u002Fg\n* Estimated glomerular filtration rate (eGFR) (calculated using the CKD-EPI formula) must be ≥30 mL\u002Fmin\u002F1.73 m².\n* Must be on a stable maximum tolerated doses of ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks\n* Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug\n\nExclusion Criteria:\n\n* Kidney biopsy indicates more than 50% tubular atrophy or interstitial fibrosis.\n* Kidney biopsy shows more than 50% formation of glomerular crescents, or clinical signs suggestive of rapidly progressive glomerulonephritis.\n* IgA nephropathy, C3 glomerulopathy, or IC-MPGN secondary to other diseases\n* Presence of other systemic diseases or kidney diseases that may cause proteinuria\n* Received immunosuppressants or other immunomodulators within 90 days prior to the first administration of the investigational drug\n* Received B-cell targeted biologics or other biologics within 180 days prior to the first administration of the investigational drug\n* Used SGLT2 inhibitors or endothelin receptor antagonists, unless have been stably used for 12 weeks or more\n* Significant comorbidities\n* History of any malignant tumors of any organ system within the past 5 years\n* History of severe trauma or major surgery within 12 weeks prior to screening, or plans to undergo surgery during the study.\n* History of immunodeficiency diseases, congenital asplenia or splenectomy.\n* History of recurrent invasive infections, active systemic bacterial, viral, or fungal infections\n* Positive test results for HBV, HCV, HIV\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \\> 2.5 times the upper limit of normal (ULN)",{"count":125,"type":22},38,[59],"This study looks at how well and safely SGB-9768 works for patients with certain kidney diseases: primary IgA nephropathy, C3 glomerulopathy, and immune complex-related membranoproliferative glomerulonephritis. It's a phase 2 trial done at several locations where both patients and doctors know what treatment is being given.",[92,129,28],"C3 Glomerulopathy","NOT_YET_RECRUITING","2025-01-20",{"date":133,"type":39},"2025-01-22",{"date":135,"type":22},"2025-04-01",{"date":137,"type":22},"2026-10-01",{"name":139,"class":46},"Suzhou Sanegene Bio Inc.",11]