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Study of Ravulizumab in Pediatric Participants With Primary IgAN
Sponsor: Alexion Pharmaceuticals, Inc.
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.
Official title: 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)
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-06-14
Completion Date
2029-11-27
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Ravulizumab
Participants will receive Ravulizumab via intravenous (IV) infusion.
Locations (14)
Research Site
Palo Alto, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Beijing, China
Research Site
Shanghai, China
Research Site
Genova, Italy
Research Site
Roma, Italy
Research Site
Torino, Italy
Research Site
Wakayama, Japan
Research Site
Seoul, South Korea
Research Site
Barcelona, Spain
Research Site
Barcelona, Spain
Research Site
Seville, Spain
Research Site
Taipei, Taiwan
Research Site
Taoyuan District, Taiwan