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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Immunoglobulin A Nephropathy

In brief

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

Key facts

Study ID

NCT05248646

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

530

Starts

2022-03-15

Expected to finish

2027-01-19

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Arizona - Site #363 — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences - Site #353 — Little Rock, Arkansas, United States
• Amicis Research Center - Site #341 — Granada Hills, California, United States
• University of CA San Diego - Site #351 — La Jolla, California, United States
• California Institute of Renal Research - Site #371 — La Mesa, California, United States
• Loma Linda University Health Care Clinical Trial Center Clinic - Site #372 — Loma Linda, California, United States
• Academic Medical Research Institute - Site #333 — Los Angeles, California, United States
• Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325 — Los Angeles, California, United States
• Stanford University - Site #370 — Palo Alto, California, United States
• North America Research Institute - Site #335 — San Dimas, California, United States
• University of California, San Francisco - Site #377 — San Francisco, California, United States
• Colorado Kidney Care PC - Site #330 — Denver, Colorado, United States
• Mayo Clinic in Florida - Site #321 — Jacksonville, Florida, United States
• South Florida Research Institute - Site #323 — Lauderdale Lakes, Florida, United States
• Columbus Research Group - Site #376 — South Miami, Florida, United States
• Fides Clinical Research North Atlanta Kidney Specialists - Site #373 — Atlanta, Georgia, United States
• Georgia Nephrology - Site #356 — Lawrenceville, Georgia, United States
• University of Iowa Hospitals & Clinics - Site #359 — Iowa City, Iowa, United States
• Kansas Nephrology Associates - Site #322 — Wichita, Kansas, United States
• Ochsner Medical Center - Site #334 — New Orleans, Louisiana, United States
• University of Maryland - Site #355 — Baltimore, Maryland, United States
• MGH Harvard - Site #369 — Boston, Massachusetts, United States
• Brigham and Women's Hospital, Division of Renal Medicine - Site #379 — Boston, Massachusetts, United States
• Tufts Medical Center - Site #349 — Boston, Massachusetts, United States
• University of Alabama at Birmingham - Site #336 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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