NCT06291376

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (estimated)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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, approximately 60 participants with eGFR 20-29 mL/min/1.73m2 will be enrolled in an Advanced Kidney Disease (AdKD) Cohort After Week 106, all participants have the option to enter an Open-label Ravulizumab Access Period.

Conditions

• Immunoglobulin A Nephropathy
• IgAN

Interventions

Type	Name	Description
DRUG	Ravulizumab	Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
DRUG	Placebo	Participants will receive placebo via weight-based IV infusion.

Timeline

• Start date: 2024-03-29
• Primary completion: 2026-01-05
• Completion: 2030-07-19
• First posted: 2024-03-04
• Last updated: 2026-04-16

Locations

267 sites across 28 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Saudi Arabia, Slovakia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study