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
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.
Eligibility
- Age range
- 16+ years
- Sex
- All
- Healthy volunteers
- No
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 w…
Interventions
- DrugSibeprenlimab
Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)
Locations (5)
- Clinical Research Site 330Denver, Colorado
- Clinical Research Site 369Boston, Massachusetts
- Clinical Research Site 374Dakota Dunes, South Dakota
- Clinical Research Site 324Houston, Texas
- Clinical Research Site 305Scarborough Village, Ontario