HomeTrialNCT04557462
🔬NCT04557462Phase 3RECRUITING

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

Study Summary

The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.

Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment540 participants
Primary Completion
Lead SponsorNovartis Pharmaceuticals
Data Retrieved2026-04-11 02:55:49.152743+00:00
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