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Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
NCT05248646 · View on ClinicalTrials.gov ↗
Study Summary
To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sibeprenlimab 400 mg
Study Locations (20)
California
- Amicis Research Center - Site #341 — Granada Hills
- University of CA San Diego - Site #351 — La Jolla
- California Institute of Renal Research - Site #371 — La Mesa
- Loma Linda University Health Care Clinical Trial Center Clinic - Site #372 — Loma Linda
- Academic Medical Research Institute - Site #333 — Los Angeles
- Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325 — Los Angeles
- Stanford University - Site #370 — Palo Alto
- North America Research Institute - Site #335 — San Dimas
- University of California, San Francisco - Site #377 — San Francisco
Florida
- Mayo Clinic in Florida - Site #321 — Jacksonville
- South Florida Research Institute - Site #323 — Lauderdale Lakes
- Columbus Research Group - Site #376 — South Miami
Georgia
- Fides Clinical Research North Atlanta Kidney Specialists - Site #373 — Atlanta
- Georgia Nephrology - Site #356 — Lawrenceville
Alabama
- University of Alabama at Birmingham - Site #336 — Birmingham
Arizona
- Mayo Clinic Arizona - Site #363 — Phoenix
Arkansas
- University of Arkansas for Medical Sciences - Site #353 — Little Rock
Colorado
- Colorado Kidney Care PC - Site #330 — Denver
Iowa
- University of Iowa Hospitals & Clinics - Site #359 — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2022-03-15 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05248646
The ClinicalTrials.gov registry entry for NCT05248646 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 530 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Immunoglobulin A Nephropathy appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05248646 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05248646 about?
NCT05248646 is a clinical study titled "Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)". To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy
What is the current status of trial NCT05248646?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2022-03-15. Estimated completion is 2026-12-30.
What conditions does trial NCT05248646 study?
This clinical trial studies the following conditions: Immunoglobulin A Nephropathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05248646?
The interventions under investigation include: Placebo (DRUG), Sibeprenlimab 400 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05248646?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05248646 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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