Phase 3 Study to Evaluate the Safety and Effectiveness of Iptacopan in Adolescents and Adults with Idiopathic IC-MPGN

What this Trial Is About

Researchers are evaluating the efficacy and safety of iptacopan LNP023 in people aged 12 to 60 years with idiopathic immune complex-mediated membranoproliferative glomerulonephritis IC-MPGN. This Phase III, multicenter, randomized, double-blind, placebo-controlled study aims to examine whether iptacopan can reduce protein in the urine and improve kidney function compared to placebo. The study also looks at changes in patient-reported fatigue. IC-MPGN is linked to problems with the alternative complement pathway, which affects disease progression. Participants will receive either iptacopan 200 mg twice daily or a matching placebo, both given alongside standard care. Adolescents receive adjusted doses 2x100 mg b.i.d., while adults receive 200 mg b.i.d. The study includes a double-blind treatment period lasting 18 months. After this period, participants can either stop iptacopan and enter a 30-day safety follow-up or continue iptacopan treatment in an open-label extension study. During the study, participants will undergo regular urine collections to measure protein levels, kidney function tests eGFR, and assessments of fatigue using a patient questionnaire. Researchers will monitor safety through vital signs, ECGs, laboratory tests, and heart function parameters. The total participation lasts up to 18 months with additional safety follow-up or extension treatment options afterward.

Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN