A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
Start Date
9/20/2021
Completion Date
12/4/2030
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.
Detailed Description
This is an open-label, non-randomized, multicenter roll-over extension program (REP) to: * CLNP023X2203, a Phase II trial investigating the dose ranging effects of LNP023 on efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability in primary IgAN patients, and * CLNP023A2301, a Phase III trial, investigating the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of LNP023 in patients with primary IgAN. Subjects completing the CLNP023X2203 and CLNP023A2301 trials on study drug, who want to continue treatment and who meet the inclusion/exclusion requirements of the roll over extension program, will have the opportunity to receive iptacopan until: * 3 years from LPFV of this study CLNP023A2002B, or * the participant no longer derives benefit from iptacopan according to the Investigator, or * the benefit-risk profile of the product in IgAN is no longer positive, or * initiation of maintenance hemodialysis, kidney transplantation or eGFR \< 15 mL/min/1.73m2 , or * the product becomes commercially available in a specific country following product launch and subsequent reimbursement for IgAN, where applicable, or * if a marketing application or reimbursement of an investigational product is rejected/not pursued in a region/country for the indication under study or which ever is sooner
Eligibility Criteria
Age Range: 18 years to 100 years
Interventions
LNP023
Conditions
Locations
AZ Kidney Dise and Hypertension Ctr
Glendale, Arizona 85306
United States
Kaiser Permanente
San Diego, California 92111
United States
North America Research Institute
San Dimas, California 91773
United States
University of Colorado Anschutz
Aurora, Colorado 80045
United States
Nephrology Associates PA
Newark, Delaware 19713
United States
CaRe Research
Chubbuck, Idaho 83202
United States
Nep Assoc of Northern Illinois
Hinsdale, Illinois 60521
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts 02115
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Clin Rsrch Consult a JCCT Company
Kansas City, Missouri 64112
United States
DaVita Clinical Research
Las Vegas, Nevada 89146
United States
New Jersey Kidney Care
Jersey City, New Jersey 07305
United States
Col Uni Med Center New York Presby
New York, New York 10032
United States
Dallas Renal Group
Dallas, Texas 75230
United States
Prolato Clinical Research Center
Houston, Texas 77054
United States
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Leuven, 3000
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Curitiba, Paraná 80440-020
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Porto Alegre, Rio Grande do Sul 90035-074
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São José do Rio Preto, São Paulo 15090 000
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