Long-term Evaluation of Iptacopan Capsules for Treating C3 Glomerulopathy and Immune-complex-membranoproliferative Glomerulonephritis

What this Trial Is About

Researchers are evaluating the long-term effects of iptacopan in people with C3 glomerulopathy C3G or idiopathic immune-complex-membranoproliferative glomerulonephritis IC-MPGN. This open-label extension study focuses on assessing the safety, tolerability, and sustained efficacy of iptacopan over an extended period, following participants who completed earlier phase 2 or phase 3 studies. The study aims to provide important data to support regulatory submissions and continued access to treatment. Participants receive iptacopan capsules at a dose of 200 mg twice daily. The study includes different groups based on prior study participation and kidney status, including those with native kidneys and kidney transplants, as well as participants from core phase 3 studies who were randomized to placebo or iptacopan. This extension study is planned to continue until iptacopan becomes commercially available, the benefit-risk profile changes, or the program is discontinued, potentially lasting up to approximately 168 months. During the study, participants undergo regular efficacy and safety assessments, including monitoring of renal endpoints, adverse events, vital signs, electrocardiograms, and laboratory tests. Data collected includes urine protein and albumin levels, serum creatinine, estimated glomerular filtration rate, and complement C3 levels. The study expects participants to remain for a minimum of 60 months and up to 84 months, with the goal of understanding long-term treatment effects and tolerability.

Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN