Research Project

Project Title:	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)
Project Type:	Clinical Trial, Enrolment not yet started Adjunct biobank: DNA, Serum, Plasma, Urine
Disease group(s):	Immune glomerulopathies
Project Summary:	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.
Lead principal investigator(s):	Enrico Verrina, Genoa
Co-investigator(s):	Edoardo La Porta, Genoa
Project Period:	03/2025 - 12/2030
Sponsors:	Industry
ClinicalTrials.gov:	NCT06291376