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Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
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
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