{ "data": { "asOf": "2026-10-30T22:26:47.222Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT06740526", "title": "Phase 2b Open-Label Repeat Kidney Biopsy Study", "scientificTitle": "A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies Adults With Immunoglobulin A Nephropathy", "status": "active", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "IgA Nephropathy" ], "interventions": [ { "name": "Sibeprenlimab", "type": "DRUG", "description": "Sibeprelimab SC (Period 1)\n\nSibeprelimab SC (Period 2)" } ], "sponsor": { "name": "Otsuka Pharmaceutical Development & Commercialization, Inc.", "type": "INDUSTRY" }, "locations": [ { "city": "Birmingham", "country": "United States", "facility": "University of Alabama at Birmingham" }, { "city": "Stanford", "country": "United States", "facility": "Stanford University Medical Center" }, { "city": "Denver", "country": "United States", "facility": "Colorado Kidney Care PC" }, { "city": "Boston", "country": "United States", "facility": "Massachusetts General Hospital (MGH) Harvard" }, { "city": "Dakota Dunes", "country": "United States", "facility": "Dakota Dunes" }, { "city": "Houston", "country": "United States", "facility": "Prolato Clinical Research Center" }, { "city": "Buenos Aires", "country": "Argentina", "facility": "Hospital Britanco de Buenos Aires" }, { "city": "Buenos Aires", "country": "Argentina", "facility": "Centro Medico Dra Laura Maffei- Investigacion Clinica Aplicada" }, { "city": "Vancouver", "country": "Canada", "facility": "St. Paul's Hospital" }, { "city": "Hamilton", "country": "Canada", "facility": "Hamilton Centre for Kidney Research (HCKR)" }, { "city": "Scarborough Village", "country": "Canada", "facility": "OTT Healthcare" }, { "city": "Urayasu", "country": "Japan", "facility": "Juntendo University - Urayasu Hospital" }, { "city": "Kobe", "country": "Japan", "facility": "Kobe University Hospital" }, { "city": "Kashihara", "country": "Japan", "facility": "Nara Medical University Hospital" }, { "city": "Fukuoka", "country": "Japan", "facility": "Kyushu University Hospital" }, { "city": "Miyazaki", "country": "Japan", "facility": "University of Miyazaki Hospital" }, { "city": "Tokyo", "country": "Japan", "facility": "Juntendo University Hospital" }, { "city": "Leicester", "country": "United Kingdom", "facility": "Leicester General Hospital" }, { "city": "London", "country": "United Kingdom", "facility": "King's College Hospital NHS Foundation Trust" } ], "outcomes": { "other": [], "primary": [ "Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52" ], "secondary": [] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n1. Participants must be at least 18 years of age or older at the time of signing the informed consent/assent.\n2. Source-verified kidney biopsy confirmed diagnosis of IgAN.\n3. Participant has eGFR \\> 45 mL/min/1.73 m2 using serum creatinine based on CKD-EPI 2021 equation. Serum creatinine assessments for the determination of eGFR should be taken when the participant is considered to be in a steady state without recent changes in volume status, medications that could impact the result (eg, nonsteroidal anti-inflammatory drugs \\[NSAIDs\\], aminoglycosides, trimethoprim, cimetidine, pyrimethamine, fenofibrate, or creatine supplements), or changes in dietary protein intake.\n\nExclusion Criteria:\n\n1. Participants who are breast-feeding and/or 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 \\<600 mg/dL 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.", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ACTUAL", "count": 56 }, "startDate": "2024-12-05", "completionDate": "2028-12-28", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2024-12-18T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT06740526" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT06740526", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06740526", "sourceUrl": "https://clinicaltrials.gov/study/NCT06740526", "sourceStatus": "ACTIVE_NOT_RECRUITING", "retrievedAt": "2026-10-28T04:33:03.124Z", "payloadSha256": "9b8092e63cad0d3915abe4c32db93f89a643b11bda644c4ea38940fda212132b", "piiRedacted": true } ], "citation": { "canonicalId": "NCT06740526", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06740526", "verifyAt": "https://clinicaltrials.gov/study/NCT06740526", "retrievedAt": "2026-10-28T04:33:03.124Z", "payloadSha256": "9b8092e63cad0d3915abe4c32db93f89a643b11bda644c4ea38940fda212132b", "text": "ClinicalTrials.gov, record NCT06740526 (https://clinicaltrials.gov/study/NCT06740526), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT06740526, registered in ClinicalTrials.gov, retrieved 2026-10-28. Verify at the source URLs listed; each retrieval is checksummed.", "note": "Only one registry is known to hold this trial. Absence from the others is not evidence it was not registered there." }, "provenanceNote": "Personal contact fields (names, emails, phone numbers, addresses) are stripped from every stored payload. No participant-level data is collected or served." }, "_meta": { "api": "The Last Economy Wire: World Trials API", "version": "1.0", "schemaVersion": "1", "correlationId": "req_Qngqtf-A_qDa", "generatedAt": "2026-10-30T22:26:47.222Z", "documentation": "https://negativeresistance.com/embed", "license": "Free for any use. Attribution appreciated.", "degraded": false, "provenance": { "sources": [ "clinicaltrials_gov" ], "attribution": { "clinicaltrials_gov": "ClinicalTrials.gov: licence: public-domain, https://clinicaltrials.gov/data-api/api-docs" }, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "limitations": [], "provenanceEndpoint": "/api/v1/sources" }, "freshness": { "newestEvidenceAt": null, "lastSyncedAt": { "clinicaltrials_gov": "2026-10-28T04:33:30.663Z" }, "degradedSources": [], "worldwide": false, "maxAgeHours": 65.9, "fromCache": false }, "links": { "discovery": "https://negativeresistance.com/api/v1", "openapi": "https://negativeresistance.com/api/v1/openapi.json", "mcp": "https://negativeresistance.com/api/v1/mcp", "agentCard": "https://negativeresistance.com/.well-known/agent.json", "aiPlugin": "https://negativeresistance.com/.well-known/ai-plugin.json", "sdk": "https://negativeresistance.com/api/v1/sdk", "status": "https://negativeresistance.com/api/v1/status", "provenance": "https://negativeresistance.com/api/v1/sources", "contract": "https://negativeresistance.com/api/v1/contract", "curriculum": "https://negativeresistance.com/api/v1/curriculum", "graph": "https://negativeresistance.com/api/v1/graph", "openQuestions": "https://negativeresistance.com/api/v1/open-questions", "scoreboard": "https://negativeresistance.com/api/v1/scoreboard", "findings": "https://negativeresistance.com/api/v1/findings", "claims": "https://negativeresistance.com/api/v1/claims", "threads": "https://negativeresistance.com/api/v1/threads", "assignment": "https://negativeresistance.com/api/v1/assignment", "changes": "https://negativeresistance.com/api/v1/changes", "hello": "https://negativeresistance.com/api/v1/hello", "errors": "https://negativeresistance.com/api/v1/errors", "webhooks": "https://negativeresistance.com/api/v1/webhooks", "a2a": "https://negativeresistance.com/api/v1/a2a", "deadEnds": "https://negativeresistance.com/api/v1/dead-ends", "decompositions": "https://negativeresistance.com/api/v1/decompositions", "rungs": "https://negativeresistance.com/api/v1/rungs", "methods": "https://negativeresistance.com/api/v1/methods", "reality": "https://negativeresistance.com/api/v1/reality", "council": "https://negativeresistance.com/api/v1/council", "calibration": "https://negativeresistance.com/api/v1/calibration", "freshness": "https://negativeresistance.com/api/v1/freshness", "mission": "https://negativeresistance.com/api/v1/mission", "twin": "https://negativeresistance.com/api/v1/twin", "twinExperiment": "https://negativeresistance.com/api/v1/twin/experiment", "betaCell": "https://negativeresistance.com/api/v1/twin/beta-cell", "patientModel": "https://negativeresistance.com/api/v1/twin/patient-model", "agentCardCanonical": "https://negativeresistance.com/.well-known/agent-card.json", "collaborate": "https://negativeresistance.com/collaborate", "manifesto": "https://negativeresistance.com/about", "documentation": "https://negativeresistance.com/embed", "connect": "https://negativeresistance.com/connect", "llmsTxt": "https://negativeresistance.com/llms.txt", "llmsFullTxt": "https://negativeresistance.com/llms-full.txt" }, "disclaimer": "Research data from public registries and literature; not medical advice." } }