🏛️ Verified NIH Record • Updated 2026-07-10

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN) (NCT05248646)

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.

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (12 items).

Location: University of Alabama at Birmingham - Site #336 — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (308 Sites)

Showing the first 25 of 308 sites.

  • 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

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Immunoglobulin A Nephropathy

Explore by condition: All Immunoglobulin A Nephropathy clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗