Research Project

Project Title:	Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) (I CAN)
Project Type:	Clinical Trial, Enrolment not yet started
Disease group(s):	Immune glomerulopathies
Project Summary:	The I CAN study will enroll approximately 450 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, 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 20 participants with eGFR 20-29 mL/min/1.73m2 will be enrolled in an Exploratory Cohort and will receive open label weight-based IV infusion of ravulizumab. After Week 106, all participants have the option to enter a post-study access period and receive open-label ravulizumab.
Lead principal investigator(s):	Smaragdi Marinaki, Athens
Co-investigator(s):	Chrysanthi Skalioti, Athens Stathis Tsiakas, Athens Christina Melexopoulou, Athens
Project Period:	04/2024 - 10/2029