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NCT05248646 · ClinicalTrials.gov registry record · Phase 3
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
A Phase 3 study of Immunoglobulin A Nephropathy, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Active
- Registry status
- Phase 3
- Development phase
- 530
- Enrollment target
- 20
- Study locations
NCT05248646 is a Phase 3 study of Immunoglobulin A Nephropathy that is active but no longer recruiting, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 530 participants, above the 264-participant average among 13 other Immunoglobulin A Nephropathy trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT05248646, a Phase 3 study of Immunoglobulin A Nephropathy, is active but no longer recruiting, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 530 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 530 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 264-participant average among 13 other Immunoglobulin A Nephropathy trials with a reported enrollment target (101% higher). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
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.
NCT05248646 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Georgia.
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.
What interventions are being tested in trial NCT05248646?
The interventions under investigation include: Placebo (DRUG), Sibeprenlimab 400 mg (DRUG).
Who is sponsoring clinical trial NCT05248646?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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