Trials / Recruiting
RecruitingNCT07024563
Study of Ravulizumab in Pediatric Participants With Primary IgAN
A Phase 3, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Ravulizumab in Pediatric Participants (2 to < 18 Years of Age) With Primary Immunoglobulin A Nephropathy (IgAN)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to characterize ravulizumab pharmacokinetics (PK) and pharmacodynamics (PD), and to evaluate safety and efficacy following ravulizumab IV dosing in pediatric participants with IgAN or IgAVN.
Conditions
- IgAN
- IgAVN
- Immunoglobulin A Nephropathy
- Immunoglobulin A Vasculitis Associated Nephritis
- Henoch-schonlein Purpura Nephritis
- IgA Vasculitis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ravulizumab | Participants will receive Ravulizumab via intravenous (IV) infusion. |
Timeline
- Start date
- 2025-06-14
- Primary completion
- 2028-07-12
- Completion
- 2029-11-27
- First posted
- 2025-06-17
- Last updated
- 2026-03-17
Locations
14 sites across 7 countries: United States, China, Italy, Japan, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07024563. Inclusion in this directory is not an endorsement.