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NCT04557462 · ClinicalTrials.gov record · last posted 2026-07-30

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

StatusActive, Not Recruiting
PhasePhase 3
Started2021-09-20
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 5 changes detected by DataLookout

2026-06-02
notable
Trial status changed: Recruiting → Active, Not Recruiting
2026-06-02
notable
Enrollment reduced: 540 → 448 participants
2026-06-02
minor
Trial sites reduced: 161 → 155 locations
2026-05-07
minor
Primary completion moved earlier: 2032-10-25 → 2030-12-04
2026-05-07
minor
Completion moved earlier: 2032-10-25 → 2030-12-04
Trial Details
NCT Number NCT04557462
Lead Sponsor Novartis Pharmaceuticals
Conditions Primary IgA Nephropathy
Enrollment 448 participants
Start Date 2021-09-20
Primary Completion 2030-12-04 (estimated)
Study Completion 2030-12-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-30