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Clinical Trials in the USA / NCT05248646
Active, not recruiting Phase 3

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

NCT05248646 · tracked via the Priya Life Science USA tracker
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase
Phase 3
Started
2022-03-15
Last updated
2026-07-14

Condition(s) studied

Immunoglobulin A Nephropathy

Investigational drug(s) / intervention(s)

Sibeprenlimab 400 mgPlacebo

Sibeprenlimab 400 mg: Solution for Injection

Placebo: Placebo s.c. q 4 weeks

Study summary

To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Male and female patients ≥ 18 years of age . * Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit). * Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements. * Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day * eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- \<30 mL/min/1.73 m2), calculated using the 2021 CKD-EPI equation Exclusion Criteria: * Secondary forms of IgAN or IgA vasculitis. * Coexisting chronic kidney disease other than IgAN. * Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable. * Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of \> 50% tubulo-interstitial fibrosis, or crescents in \> 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort. * Nephrotic syndrome * Serum IgG \< 600 mg/dL at screening. * Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization * Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer. * Chronic infectious disease, or acute infectious disease at time of screening. * Type 1 diabetes, or poorly controlled Type 2 diabetes * Uncontrolled hypertension The protocol provides additional information about these and other inclusion and exclusion criteria.

Primary outcome measure(s)

Trial sites (308)

FacilityCityRegionStatus
University of Alabama at Birmingham - Site #336 Birmingham Alabama
Mayo Clinic Arizona - Site #363 Phoenix Arizona
University of Arkansas for Medical Sciences - Site #353 Little Rock Arkansas
Amicis Research Center - Site #341 Granada Hills California
University of CA San Diego - Site #351 La Jolla California
California Institute of Renal Research - Site #371 La Mesa California
Loma Linda University Health Care Clinical Trial Center Clinic - Site #372 Loma Linda California
Academic Medical Research Institute - Site #333 Los Angeles California
Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325 Los Angeles California
Stanford University - Site #370 Palo Alto California
North America Research Institute - Site #335 San Dimas California
University of California, San Francisco - Site #377 San Francisco California
Colorado Kidney Care PC - Site #330 Denver Colorado
Mayo Clinic in Florida - Site #321 Jacksonville Florida
South Florida Research Institute - Site #323 Lauderdale Lakes Florida
Columbus Research Group - Site #376 South Miami Florida
Fides Clinical Research North Atlanta Kidney Specialists - Site #373 Atlanta Georgia
Georgia Nephrology - Site #356 Lawrenceville Georgia
University of Iowa Hospitals & Clinics - Site #359 Iowa City Iowa
Kansas Nephrology Associates - Site #322 Wichita Kansas
Ochsner Medical Center - Site #334 New Orleans Louisiana
University of Maryland - Site #355 Baltimore Maryland
MGH Harvard - Site #369 Boston Massachusetts
Brigham and Women's Hospital, Division of Renal Medicine - Site #379 Boston Massachusetts
Tufts Medical Center - Site #349 Boston Massachusetts
Beth Israel Deaconess Medical Center - Site #337 Boston Massachusetts
MGH Harvard - Site #369 Boston Massachusetts
Brigham and Women's Hospital, Division of Renal Medicine - Site #379 Boston Massachusetts
Tufts Medical Center - Site #349 Boston Massachusetts
Beth Israel Deaconess Medical Center - Site #337 Boston Massachusetts
UMASS Memorial Medical Center - Site #331 Worcester Massachusetts
UMASS Memorial Medical Center - Site #331 Worcester Massachusetts
St. Clair Nephrology Research - Site #320 Roseville Michigan
University of Minnesota - Site #345 Minneapolis Minnesota
Mayo Clinic - Rochester - Site #332 Rochester Minnesota
University of Nebraska Medical Center - Site #347 Omaha Nebraska
Davita Clinical Research - Las Vegas - Site #327 Las Vegas Nevada
Northwell Health - North Shore University Hospital NSUH - Site #346 Great Neck New York
New York University Grossman School of Medicine - Site #362 New York New York
Jacobi Medical Center - Site #364 The Bronx New York

+ 268 more sites — see the full list on the official registry below.

More Otsuka Pharmaceutical Development & Commercialization, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05248646 on ClinicalTrials.gov ↗ ← All trials in the USA