[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572996":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":92,"collaborators":11,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":11,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":11,"enrollmentInfo":103,"targetDuration":11,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Otsuka Pharmaceutical Development & Commercialization, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sibeprenlimab","EXPERIMENTAL",null,[13],"Drug: Sibeprenlimab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Sibeprelimab SC (Period 1)\n\nSibeprelimab SC (Period 2)",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Otsuka Call Center","CONTACT","844-687-8522","Otsuka-ProfessionalServices@otsuka-us.com",[26,42,54,66,78],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Clinical Research Site 330","RECRUITING","Denver","Colorado","80230","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-104.9847,39.73915,{"lat":38,"lon":37},[41],{"name":21,"role":22,"phone":11,"phoneExt":11,"email":11},{"facility":43,"status":28,"city":44,"state":45,"zip":46,"country":32,"countryCode":33,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"Clinical Research Site 369","Boston","Massachusetts","21144",{"type":35,"coordinates":48},[49,50],-71.05977,42.35843,{"lat":50,"lon":49},[53],{"name":21,"role":22,"phone":11,"phoneExt":11,"email":11},{"facility":55,"status":28,"city":56,"state":57,"zip":58,"country":32,"countryCode":33,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Clinical Research Site 374","Dakota Dunes","South Dakota","57409",{"type":35,"coordinates":60},[61,62],-96.48642,42.48749,{"lat":62,"lon":61},[65],{"name":21,"role":22,"phone":11,"phoneExt":11,"email":11},{"facility":67,"status":28,"city":68,"state":69,"zip":70,"country":32,"countryCode":33,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Clinical Research Site 324","Houston","Texas","77054",{"type":35,"coordinates":72},[73,74],-95.36327,29.76328,{"lat":74,"lon":73},[77],{"name":21,"role":22,"phone":11,"phoneExt":11,"email":11},{"facility":79,"status":28,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Clinical Research Site 305","Scarborough Village","Ontario","M1H 3G4","Canada","CA",{"type":35,"coordinates":86},[87,88],-79.22124,43.73899,{"lat":88,"lon":87},[91],{"name":21,"role":22,"phone":11,"phoneExt":11,"email":11},{"type":93,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100572996","phase-2-trial-of-the-impact-of-sibeprenlimab-on-immunoglobulin-a-nephropathy-kidney-tissue-100572996",false,"NCT06740526","Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue","A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy","Inclusion Criteria:\n\n1. Participants must be at least 16 years of age or older at the time of signing the informed consent\u002Fassent.\n2. Source-verified kidney biopsy confirmed diagnosis of IgAN.\n3. Participant has estimated glomerular filtration rate (eGFR) \\> 45 mL\u002Fmin\u002F1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration \\[CKD EPI\\] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 \\[CKiD U25\\] eGFR equation for those younger than 18 years)\n\nExclusion Criteria:\n\n1. Participants who are breast-feeding and\u002For who have a positive pregnancy test result prior to receiving sibeprenlimab.\n2. Participant has coexisting chronic kidney disease, other than IgAN.\n3. Participant has a serum IgG value \\\u003C600 mg\u002FdL at screening.\n4. Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:\n\n   topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).\n5. Participant has uncontrolled hypertension (defined as systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg).\n6. Participants who would be likely to require prohibited concomitant therapy during the trial.","ALL","16 Years",{"count":104,"type":105},25,"ESTIMATED","INTERVENTIONAL",[108],"PHASE2","This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.",[111],"IgA Nephropathy","2025-04-04",{"date":114,"type":115},"2025-04-06","ACTUAL",{"date":117,"type":115},"2024-11-19",{"date":119,"type":105},"2029-04-17",{"name":5,"class":6},5]