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Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue

A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy

NCT06740526•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
•2. Source-verified kidney biopsy confirmed diagnosis of IgAN.
•3. Participant has estimated glomerular filtration rate (eGFR) \> 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration \[CKD EPI\] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 \[CKiD U25\] eGFR equation for those younger than 18 years)

Exclusion Criteria

•1. Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
•2. Participant has coexisting chronic kidney disease, other than IgAN.
•3. Participant has a serum IgG value \<600 mg/dL at screening.
•4. Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:
•topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).
•5. Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg).
•6. Participants who would be likely to require prohibited concomitant therapy during the trial.

Locations (5)

Clinical Research Site 330

Denver, Colorado, United States

Clinical Research Site 369

Boston, Massachusetts, United States

Clinical Research Site 374

Dakota Dunes, South Dakota, United States

Clinical Research Site 324

Houston, Texas, United States

Clinical Research Site 305

Scarborough Village, Ontario, Canada

Key Dates

Start Date

November 19, 2024

Primary Completion Date

April 17, 2029

Completion Date

April 17, 2029

Last Updated

April 6, 2025

Enrollment

ESTIMATED participants

Conditions

IgA Nephropathy

Interventions

Sibeprenlimab

DRUG

Contacts

Otsuka Call Center

CONTACT

844-687-8522 Otsuka-ProfessionalServices@otsuka-us.com

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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: April 6, 2025Data 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 the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Study of the Link Between Complement Activation and IgA Nephropathy Severity

A Study of Probiotics in IgA Nephropathy

National Registry of Rare Kidney Diseases

IgA Nephropathy Registration Initiative of High Quality (INSIGHT)

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