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A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-09-20
Primary completion: 2032-10-22
Study completion finish: 2032-10-22
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT04557462
Intervention or treatment
DRUG: LNP023
Conditions
- • Primary IgA Nephropathy
Find a site
Closest Location:
Novartis Investigative Site
Research sites nearby
Select from list below to view details:
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: LNP023
| DRUG: LNP023
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Number and percentage of participants with serious adverse event | Summary statistics on serious adverse events | 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 | 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 | 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 | 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 | 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 | Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Annualized total eGFR slope | Annualized rate of renal disease progression as measured by mean eGFR slope at post baseline visits | 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 | 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) | Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter |
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