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RECRUITING
NCT06740526
PHASE2

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2024-11-19

Completion Date

2029-04-17

Last Updated

2025-04-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

Sibeprenlimab

Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)

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