Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Immunoglobulin A Nephropathy, sponsored by Otsuka Pharmaceutical Development & Commercialization.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT05248646 still lists
NCT05248646 is an interventional study that assigns participants to a tested intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap, above the 264-participant average among 13 other Immunoglobulin A Nephropathy trials with a reported enrollment target (101% higher).
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 names 20 study sites across 9 states, led by 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
Similar trials for Immunoglobulin A Nephropathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05248646's enrollment target sits among peer trials
530 2nd of 13 the highest of 13 other Immunoglobulin A Nephropathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Immunoglobulin A Nephropathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Ravulizumab in Pediatric Participants With Primary IgAN
RECRUITING · Phase 3
-
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
RECRUITING · Phase 3
-
Atrasentan in Patients With IgA Nephropathy
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Zigakibart in Adults With IgA Nephropathy
ACTIVE NOT RECRUITING · Phase 3
-
Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
ACTIVE NOT RECRUITING · Phase 3
-
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06646276 · 530 participants · Phase 3
A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
- NCT06703476 · 530 participants · Phase 3
A Study of Surgical Techniques During Cystectomy
- NCT06880744 · 530 participants · Phase 3
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
- NCT07138040 · 530 participants · NA
Re-Engaging AYA Survivors in Cancer-Related Healthcare
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI