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
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective of this study is to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with ravulizumab IV in pediatric participants to support the extrapolation of efficacy from the adult population.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:
• 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 ≥ 0.5 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
Locations
United States
Colorado
Research Site
RECRUITING
Aurora
Other Locations
China
Research Site
NOT_YET_RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Shanghai
Italy
Research Site
RECRUITING
Genova
Research Site
RECRUITING
Roma
Research Site
RECRUITING
Torino
Republic of Korea
Research Site
RECRUITING
Seoul
Spain
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Seville
Taiwan
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taoyuan District
Contact Information
Primary
Alexion Pharmaceuticals, Inc. (Sponsor)
clinicaltrials@alexion.com
1-855-752-2356
Time Frame
Start Date:2025-06-14
Estimated Completion Date:2028-11-23
Participants
Target number of participants:18
Treatments
Experimental: Ravulizumab
All participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by weight-based maintenance treatment with ravulizumab on Day 15 and either once every 8 weeks (q8w) thereafter or once every 4 weeks (q4w) depending on weight.