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Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

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.

NCT05248646•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sibeprenlimab 400 mg administered SC Q 4 weeks compared to placebo in patients with IgAN. The primary objective is to compare the relative change from baseline in the urinary protein to creatinine ratio (uPCR) in 24-hour urine collections, after 9 months of treatment. The key secondary objective is to compare the annualized rate of change from baseline (slope) of estimated glomerular filtration rate (eGFR) after approximately 24 months of treatment. There will be one main cohort comprised of approximately 450 subjects with source-verified biopsy-confirmed IgAN and eGFR ≥ 30 mL/min/1.73 m\^2. An additional exploratory cohort will be comprised of up to 20 subjects with source-verified biopsy confirmed IgAN and eGFR of 20 to \< 29 mL/min/1.73 m\^2.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (308)

University of Alabama at Birmingham - Site #336

Birmingham, Alabama, United States

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

Key Dates

Start Date

March 15, 2022

Primary Completion Date

May 7, 2026

Completion Date

December 30, 2026

Last Updated

February 20, 2026

Enrollment

530

ACTUAL participants

Conditions

Immunoglobulin A Nephropathy

Interventions

Sibeprenlimab 400 mg

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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