{ "data": { "asOf": "2026-10-30T22:24:25.956Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07850752", "title": "A Study of the Efficacy and Safety of Zigakibart + Atrasentan in Adult Patients With Primary IgA Nephropathy", "scientificTitle": "A Phase IIIb, Multi-center, Two-arm, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Zigakibart and Atrasentan Versus Zigakibart and Placebo in Patients With Primary IgA Nephropathy", "status": "not_yet_recruiting", "studyType": "interventional", "phase": [ "PHASE3" ], "conditions": [ "IgA Nephropathy (IgAN)" ], "interventions": [ { "name": "zigakibart", "type": "BIOLOGICAL", "description": "Solution for injection via PFS-NSD" }, { "name": "atrasentan", "type": "DRUG", "description": "Tablet" }, { "name": "Placebo", "type": "DRUG", "description": "Tablet" } ], "sponsor": { "name": "Novartis Pharmaceuticals", "type": "INDUSTRY" }, "locations": [], "outcomes": { "other": [], "primary": [ "Change in proteinuria from Baseline to Week 36, based on 24 hour urine collection" ], "secondary": [ "Rate of patients achieving proteinuria remission at Week 52", "Rate of proteinuria remission", "Proportion of participants with AEs, SAEs and AESIs", "Change from baseline in Glomerular Filtration rate (GFR)", "Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Aged ≥ 18 years at the time of signing the informed consent, prior to initiation of any study specific activities/procedures\n* Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. If a biopsy report within 10 years is not available, re-biopsy may be performed locally during Screening.\n* eGFR ≥ 30 mL/min/1.73m2 by a central laboratory at Screening, calculated using serum creatinine based on the 2021 CKD-EPI equation (Inker et al 2021)\n* UPCR ≥ 0.7 g/g (700 mg/g), as measured from a 24 hour urine collection by a central laboratory at Screening\n* Stable on a maximally tolerated dose of ACEi and/or ARB for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of SGLT2i, MRA, and/or GLP-1A if stable for at least 12 weeks prior to Screening. Participants are expected to stay on a stable dose of ACEi, ARB, SGLT2i, MRA and/or GLP-1A for the duration of the study.\n\nExclusion Criteria:\n\n* Chronic Kidney Disease (CKD), either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN\n* Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasia\n* Diagnosis of active IgA vasculitis\n* Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (2025)\n* Current clinical diagnosis of nephrotic syndrome\n* Known history of heart failure or conditions relating to fluid overload such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites\n* Current severe infection requiring antimicrobials, or history of recurrent, severe infections as determined by the Investigator\n\nOther protocol-defined inclusion/exclusion criteria may apply", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 340 }, "startDate": "2026-12-01", "completionDate": "2030-12-25", "lastUpdated": "2026-09-30T00:00:00.000Z", "firstPosted": "2026-09-30T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07850752" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07850752", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07850752", "sourceUrl": "https://clinicaltrials.gov/study/NCT07850752", "sourceStatus": "NOT_YET_RECRUITING", "retrievedAt": "2026-10-28T04:33:03.765Z", "payloadSha256": "522b771ac056c2792bd69126051ff306bb2921351518fb61117da11e85da6eb1", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07850752", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07850752", "verifyAt": "https://clinicaltrials.gov/study/NCT07850752", "retrievedAt": "2026-10-28T04:33:03.765Z", "payloadSha256": "522b771ac056c2792bd69126051ff306bb2921351518fb61117da11e85da6eb1", "text": "ClinicalTrials.gov, record NCT07850752 (https://clinicaltrials.gov/study/NCT07850752), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07850752, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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