A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
Condition: Primary IgA Nephropathy · Sponsor: Novartis Pharmaceuticals
About this study
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.
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (155)
| AZ Kidney Dise and Hypertension Ctr | Glendale, Arizona, United States | — |
| Kaiser Permanente | San Diego, California, United States | — |
| North America Research Institute | San Dimas, California, United States | — |
| University of Colorado Anschutz | Aurora, Colorado, United States | — |
| CaRe Research | Chubbuck, Idaho, United States | — |
| Nep Assoc of Northern Illinois | Hinsdale, Illinois, United States | — |
| Johns Hopkins Hospital | Baltimore, Maryland, United States | — |
| Brigham and Womens Hosp Harvard Med School | Boston, Massachusetts, United States | — |
| Mayo Clinic Rochester | Rochester, Minnesota, United States | — |
| Clin Rsrch Consult a JCCT Company | Kansas City, Missouri, United States | — |
| DaVita Clinical Research | Las Vegas, Nevada, United States | — |
| New Jersey Kidney Care | Jersey City, New Jersey, United States | — |
+ 143 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04557462