Study of Ravulizumab in Pediatric Participants With Primary IgAN

Recruiting Phase 3 Interventional Study
IgAN IgAVN Immunoglobulin A Nephropathy Immunoglobulin A Vasculitis Associated Nephritis Henoch-schonlein Purpura Nephritis IgA Vasculitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
2 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Alexion Pharmaceuticals, Inc. · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
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.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
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 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/…
Contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356

clinicaltrials@alexion.com

CONTACT