A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
NCT04557462
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Primary IgA Nephropathy
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Novartis Pharmaceuticals
- Last updated on ClinicalTrials.gov
- October 5, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
New York · 1
- Col Uni Med Center New York Presby · New York, NY
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.