Study of Ravulizumab in Pediatric Participants With Primary IgAN

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-18
SponsorAlexion Pharmaceuticals, Inc.

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

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators