[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658205":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":42,"studyPopulation":32,"armGroups":43,"interventions":57,"overallOfficials":77,"centralContacts":81,"locations":32,"responsibleParty":88,"collaborators":32,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":32,"enrollmentInfo":100,"targetDuration":32,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":119,"whyStopped":32,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":32},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Change in proteinuria from Baseline to Week 36, based on 24 hour urine collection","Relative difference between treatment groups in mean change of natural log 24-hour UPCR from Baseline to Week 36, expressed as percent reduction","Baseline, Week 36",[14,18,21,25,29],{"measure":15,"description":16,"timeFrame":17},"Rate of patients achieving proteinuria remission at Week 52","Difference between the treatment groups in the rate of patients achieving proteinuria remission, defined as 24-hour UPCR \\\u003C 0.5 g\u002Fg","Week 52",{"measure":19,"description":20,"timeFrame":17},"Rate of proteinuria remission","Difference between the treatment groups in the rate of proteinuria remission, defined as 24-hour UPCR of \\\u003C 0.3 g\u002Fg",{"measure":22,"description":23,"timeFrame":24},"Proportion of participants with AEs, SAEs and AESIs","Proportion of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of special interest (AESIs)","128 Weeks",{"measure":26,"description":27,"timeFrame":28},"Change from baseline in Glomerular Filtration rate (GFR)","Change from baseline in GFR (safety laboratory parameters)","Baseline and up to 104 weeks",{"measure":30,"description":31,"timeFrame":28},"Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)","Change from baseline in SBP and DBP (vital signs)",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":39},"DOUBLE",[40,41],"PARTICIPANT","INVESTIGATOR","The study includes a 52-week double-blind treatment period and a 52-week open-label extension (OLE):\n\n* Double-blind treatment period: Participants will receive zigakibart and either atrasentan or matching placebo. The purpose is to evaluate if zigakibart + atrasentan demonstrates increased efficacy in reducing proteinuria and delaying progression of disease compared to zigakibart + placebo. It also aims to evaluate the safety and tolerability of zigakibart + atrasentan.\n* OLE: Participants will receive zigakibart and atrasentan. The purpose is to provide study participants with the opportunity to continue to receive zigakibart and atrasentan, while enabling continued collection of long-term efficacy, safety, and tolerability data.",[44,51],{"label":45,"type":46,"description":47,"interventionNames":48},"zigakibart + atrasentan","EXPERIMENTAL","Patients receive zigakibart and atrasentan",[49,50],"Biological: zigakibart","Drug: atrasentan",{"label":52,"type":53,"description":54,"interventionNames":55},"zigakibart + placebo","ACTIVE_COMPARATOR","Patients receive zigakibart and matching placebo",[49,56],"Drug: Placebo",[58,66,74],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"BIOLOGICAL","zigakibart","Solution for injection via PFS-NSD",[45,52],[64,65],"BION-1301","FUB523",{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"DRUG","atrasentan","Tablet",[45],[72,73],"CHK01","EXV811",{"type":67,"name":75,"description":69,"armGroupLabels":76,"otherNames":32},"Placebo",[52],[78],{"name":79,"affiliation":79,"role":80},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[82,86],{"name":79,"role":83,"phone":84,"phoneExt":32,"email":85},"CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":79,"role":83,"phone":87,"phoneExt":32,"email":32},"+41613241111",{"type":89,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100658205","phase-3-a-study-of-the-efficacy-and-safety-of-zigakibart--atrasentan-in-adult-patients-with-primary-iga-nephropathy-100658205",false,"NCT07850752","A Study of the Efficacy and Safety of Zigakibart + Atrasentan in Adult Patients With Primary IgA Nephropathy","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","LUMINA IgAN","Inclusion Criteria:\n\n* Aged ≥ 18 years at the time of signing the informed consent, prior to initiation of any study specific activities\u002Fprocedures\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\u002Fmin\u002F1.73m2 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\u002Fg (700 mg\u002Fg), as measured from a 24 hour urine collection by a central laboratory at Screening\n* Stable on a maximally tolerated dose of ACEi and\u002For 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\u002For 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\u002For 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\u002Fpodocytopathy 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\u002Fexclusion criteria may apply","ALL","18 Years",{"count":101,"type":102},340,"ESTIMATED","INTERVENTIONAL",[105],"PHASE3","This is a Phase IIIb, multicenter, two-arm, randomized, double-blind, parallel group study to evaluate the efficacy and safety of zigakibart + atrasentan compared to zigakibart + placebo in patients with primary IgAN at risk of disease progression.",[108],"IgA Nephropathy (IgAN)",[110,111,112,113,114,115,116,117,118],"Zigakibart","Atrasentan","IgA nephropathy","IgAN","Proteinuria","UPCR","eGFR","eGFR slope","Kidney function decline","NOT_YET_RECRUITING","2026-09-23",{"date":122,"type":123},"2026-09-30","ACTUAL",{"date":125,"type":102},"2026-12-01",{"date":127,"type":102},"2030-12-25",{"name":79,"class":6}]