A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN)
Alexion Pharmaceuticals, Inc.
Summary
The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.
Description
The I CAN study will enroll approximately 510 eligible participants with IgAN who are high risk of disease progression. Participants will be on stable concomitant IgAN treatment(s) consistent with standard of care for patients with IgAN for at least 3 months prior to Screening. Approximately 450 participants will be randomized in a 1:1 allocation ratio to receive a weight-based IV infusion of either ravulizumab or placebo. An interim analysis may be conducted at Week 34 to evaluate change in proteinuria and the final analysis will be conducted at Week 106 to evaluate eGFR. In addition, approxi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period for participants with eGFR ≥ 30 mL/min/1.73 m\^2. * For participants in the AdKD cohorts, eGFR 20 to 29 mL/min/1.73 m2 a kidney biopsy is required within 6 months prior to Screening or during the Screening Period. * UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine during the Screening Period. * Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening. * Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months p…
Interventions
- DrugRavulizumab
Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
- DrugPlacebo
Participants will receive placebo via weight-based IV infusion.
Locations (267)
- Research SiteAlabaster, Alabama
- Research SitePhoenix, Arizona
- Research SiteLoma Linda, California
- Research SiteLos Angeles, California
- Research SiteLos Angeles, California
- Research SiteLos Angeles, California