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.
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 RAASI (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
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.
Single group
Ravulizumab
DrugParticipants will receive Ravulizumab via intravenous (IV) infusion.
Change from Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR) at Week 34
Maximum Observed Plasma Concentration (Cmax) of Ravulizumab
Trough Serum Concentration (Ctrough) of Ravulizumab
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration
Change from Baseline in proteinuria based on Urine Protein to Creatinine Ratio (UPCR) at Week 10
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