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 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
540
Capsule 200 mg (b.i.d.) taken orally twice a day
AZ Kidney Dise and Hypertension Ctr
Glendale, Arizona, United States
RECRUITINGKaiser Permanente
San Diego, California, United States
ACTIVE_NOT_RECRUITINGNorth America Research Institute
San Dimas, California, United States
ACTIVE_NOT_RECRUITINGUniversity of Colorado Anschutz
Aurora, Colorado, United States
Number and percentage of participants with serious adverse event
Summary statistics on serious adverse events
Time frame: Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with adverse event
Summary statistics on adverse events
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with adverse events of special interest
Summary statistics on adverse events of special interest
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual adminstration of study treatment
Number and percentage of participants with abnormalities in vital signs
Summary statistics on abnormalities in vital sign parameters
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with abnormalities in ECG
Summary statistics in abnormalities in ECG parameters
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with abnormalities in clinical laboratory evaluations
Summary statistics on abnormalities in clinical laboratory evaluations
Time frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Annualized total eGFR slope
Annualized rate of renal disease progression as measured by mean eGFR slope at post baseline visits
Time frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Change from baseline in eGFR
Average change from baseline in eGFR at post-baseline visits
Time frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Log transformed ratio to baseline in UPCR, UACR
Log transformed ratio to baseline in UPCR, UACR at post-baseline visits. The log transformation refers to the natural log (base on e)
Time frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
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Nephrology Associates PA
Newark, Delaware, United States
WITHDRAWNCaRe Research
Chubbuck, Idaho, United States
ACTIVE_NOT_RECRUITINGNep Assoc of Northern Illinois
Hinsdale, Illinois, United States
ACTIVE_NOT_RECRUITINGJohns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGBrigham and Womens Hosp Harvard Med School
Boston, Massachusetts, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITING...and 151 more locations