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Active, not recruiting Phase 3 Interventional

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)

ClinicalTrials.gov ID: NCT05248646

Public ClinicalTrials.gov record NCT05248646. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 7:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.

Study identification

NCT ID
NCT05248646
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
530 participants

Conditions and interventions

Interventions

  • Sibeprenlimab 400 mg Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 14, 2022
Primary completion
May 12, 2026
Completion
Jan 18, 2027
Last update posted
Jul 13, 2026

2022 – 2027

United States locations

U.S. sites
54
U.S. states
23
U.S. cities
42
Facility City State ZIP Site status
University of Alabama at Birmingham - Site #336 Birmingham Alabama 35233
Mayo Clinic Arizona - Site #363 Phoenix Arizona 85054
University of Arkansas for Medical Sciences - Site #353 Little Rock Arkansas 72205
Amicis Research Center - Site #341 Granada Hills California 91344
University of CA San Diego - Site #351 La Jolla California 92037
California Institute of Renal Research - Site #371 La Mesa California 91942
Loma Linda University Health Care Clinical Trial Center Clinic - Site #372 Loma Linda California 92354
Academic Medical Research Institute - Site #333 Los Angeles California 90022
Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325 Los Angeles California 90027
Stanford University - Site #370 Palo Alto California 94304
North America Research Institute - Site #335 San Dimas California 91773
University of California, San Francisco - Site #377 San Francisco California 94143
Colorado Kidney Care PC - Site #330 Denver Colorado 80230
Mayo Clinic in Florida - Site #321 Jacksonville Florida 32224
South Florida Research Institute - Site #323 Lauderdale Lakes Florida 33313
Columbus Research Group - Site #376 South Miami Florida 33143
Fides Clinical Research North Atlanta Kidney Specialists - Site #373 Atlanta Georgia 30342
Georgia Nephrology - Site #356 Lawrenceville Georgia 30046
University of Iowa Hospitals & Clinics - Site #359 Iowa City Iowa 52242
Kansas Nephrology Associates - Site #322 Wichita Kansas 67214
Ochsner Medical Center - Site #334 New Orleans Louisiana 70121
University of Maryland - Site #355 Baltimore Maryland 21201
MGH Harvard - Site #369 Boston Massachusetts 02114
Brigham and Women's Hospital, Division of Renal Medicine - Site #379 Boston Massachusetts 02115
Tufts Medical Center - Site #349 Boston Massachusetts 02127
Beth Israel Deaconess Medical Center - Site #337 Boston Massachusetts 02215
MGH Harvard - Site #369 Boston Massachusetts 21144
Brigham and Women's Hospital, Division of Renal Medicine - Site #379 Boston Massachusetts 21155
Tufts Medical Center - Site #349 Boston Massachusetts 21277
Beth Israel Deaconess Medical Center - Site #337 Boston Massachusetts 22155
UMASS Memorial Medical Center - Site #331 Worcester Massachusetts 01655
UMASS Memorial Medical Center - Site #331 Worcester Massachusetts 16555
St. Clair Nephrology Research - Site #320 Roseville Michigan 48066
University of Minnesota - Site #345 Minneapolis Minnesota 55414
Mayo Clinic - Rochester - Site #332 Rochester Minnesota 55905
University of Nebraska Medical Center - Site #347 Omaha Nebraska 68198
Davita Clinical Research - Las Vegas - Site #327 Las Vegas Nevada 89107
Northwell Health - North Shore University Hospital NSUH - Site #346 Great Neck New York 11021
New York University Grossman School of Medicine - Site #362 New York New York 10016
Jacobi Medical Center - Site #364 The Bronx New York 10461
The University of Cincinnati - Site #343 Cincinnati Ohio 45267
The Ohio State University Wexner Medical Center - Site #350 Columbus Ohio 43210
Rhode Island Hospital - Site #367 Providence Rhode Island 02903
Rhode Island Hospital - Site #367 Providence Rhode Island 29033
Dunes Clinical Research LLC - Site #374 Dakota Dunes South Dakota 57029
Research Management, Inc - Site #354 Austin Texas 78751
Renal Disease Research Institute - Site #378 Dallas Texas 75235
Baylor College of Medicine (BCM) Medical Center - Site #375 Houston Texas 77030
Prolato Clinical Research Center (PCRC) - Site #324 Houston Texas 77054
Pioneer Research Solutions, Inc. - Site #339 Houston Texas 77099
UT Health Science Center at San Antonio - Site #368 San Antonio Texas 78229
Utah Kidney Research Institute - Site #342 Salt Lake City Utah 84115
University of Wisconsin - Site #352 Madison Wisconsin 53717
Medical College of Wisconsin - Site #361 Milwaukee Wisconsin 53213

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 254 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05248646, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 13, 2026 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05248646 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →