Trials / Recruiting
RecruitingNCT06740526
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sibeprenlimab | Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2) |
Timeline
- Start date
- 2024-11-19
- Primary completion
- 2029-04-17
- Completion
- 2029-04-17
- First posted
- 2024-12-18
- Last updated
- 2025-04-06
Locations
5 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06740526. Inclusion in this directory is not an endorsement.