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.
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
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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
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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/…
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