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)
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.
Eligibility
- Age range
- 2–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must be 2 to \< 18 years of age at the time of signing the informed consent or assent. * Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106. * UPCR ≥ 1.0 g/g from the mean of 3 first morning voids (FMV) collected within 1 week during the Screening Period * Estimated GFR ≥ 30 mL/min/1.73 m2 during Screening * Meningococcal infection vaccine * Haemophilus influenzae type b and Streptococcus pneumoniae vaccine * Participants who are receiving SGLT2i, DEARA…
Interventions
- DrugRavulizumab
Participants will receive Ravulizumab via intravenous (IV) infusion.
Locations (14)
- Research SitePalo Alto, California
- Research SiteAurora, Colorado
- Research SiteBeijing
- Research SiteShanghai
- Research SiteGenova
- Research SiteRoma