About this trial
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 criteria
Qualifiers
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
Disqualifiers
Diagnosis of rapidly progressive glomerulonephritis
Secondary forms of IgAN not in the context of primary IgAN or IgAV
Concomitant clinically significant renal disease other than IgAN or IgAVN
Clinical remission of IgAN/IgAVN or clinically significant improvement in proteinuria within the last 6 months.
Trial design
Treatments tested in this trial
- Ravulizumab