[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652123":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":20,"centralContacts":25,"locations":20,"responsibleParty":31,"collaborators":20,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":20,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":20,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":20,"overallStatus":52,"whyStopped":20,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":20},{"fullName":5,"class":6},"Otsuka Pharmaceutical Development & Commercialization, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sibeprenlimab","EXPERIMENTAL","Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks as an add-on to standard of care treatment at a weight-based dose.",[13,14],"Drug: Sibeprenlimab","Drug: Standard of care",[16,21],{"type":17,"name":9,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks at a weight-based dose",[9],null,{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"Standard of care","Standard of care therapy consists of angiotensin converting enzyme inhibitors (ACEIs) and\u002For angiotensin receptor blockers (ARBs)",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Otsuka Call Center","CONTACT","844-687-3522","Otsuka-ProfessionalServices@otsuka-us.com",{"type":32,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100652123","phase-3-trial-of-sibeprenlimab-in-children-and-adolescents-with-immunoglobulin-a-nephropathy-igan-100652123",false,"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.","ALL","2 Years","17 Years",{"count":44,"type":45},24,"ESTIMATED","INTERVENTIONAL",[48],"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).",[51],"IgA Nephropathy","NOT_YET_RECRUITING","2026-08-13",{"date":55,"type":56},"2026-08-18","ACTUAL",{"date":58,"type":45},"2026-09-30",{"date":60,"type":45},"2030-02-23",{"name":5,"class":6}]