Clinical Trials in Canada / NCT04557462
Active, not recruiting
Phase 3
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 · tracked via the Priya Life Science Canada tracker
Condition(s) studied
Primary IgA Nephropathy
Investigational drug(s) / intervention(s)
LNP023: Capsule 200 mg (b.i.d.) taken orally twice a day
Study 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.
Eligibility
Inclusion Criteria:
* For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period.
* eGFR\* ≥ 20 ml/min/1.73m2
\*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)
* Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.
* Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations.
* All participants must be on supportive care regimen of ACEi or ARB\* as per KDIGO guidelines.
* participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study
Exclusion Criteria:
* participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason.
* Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023.
* Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
* Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
* Participants treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure (\>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. Rituximab requires 180 days wash out.
* Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer.
* History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.
Primary outcome measure(s)
- Number and percentage of participants with serious adverse event — Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on serious adverse events - Number and percentage of participants with adverse event — Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on adverse events - Number and percentage of participants with 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
Summary statistics on adverse events of special interest - Number and percentage of participants with abnormalities in vital signs — Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics on abnormalities in vital sign parameters - Number and percentage of participants with abnormalities in ECG — Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Summary statistics in abnormalities in ECG parameters - Number and percentage of participants with 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
Summary statistics on abnormalities in clinical laboratory evaluations
Trial sites (155)
| Facility | City | Region | Status |
|---|---|---|---|
| AZ Kidney Dise and Hypertension Ctr | Glendale | Arizona | |
| Kaiser Permanente | San Diego | California | |
| North America Research Institute | San Dimas | California | |
| University of Colorado Anschutz | Aurora | Colorado | |
| CaRe Research | Chubbuck | Idaho | |
| Nep Assoc of Northern Illinois | Hinsdale | Illinois | |
| Johns Hopkins Hospital | Baltimore | Maryland | |
| Brigham and Womens Hosp Harvard Med School | Boston | Massachusetts | |
| Mayo Clinic Rochester | Rochester | Minnesota | |
| Clin Rsrch Consult a JCCT Company | Kansas City | Missouri | |
| DaVita Clinical Research | Las Vegas | Nevada | |
| New Jersey Kidney Care | Jersey City | New Jersey | |
| Col Uni Med Center New York Presby | New York | New York | |
| Dallas Renal Group | Dallas | Texas | |
| Novartis Investigative Site | Córdoba | Córdoba Province | |
| Novartis Investigative Site | Córdoba | Córdoba Province | |
| Novartis Investigative Site | CABA | Argentina | |
| Novartis Investigative Site | CABA | Argentina | |
| Novartis Investigative Site | Santa Fe | Argentina | |
| Novartis Investigative Site | Woolloongabba | Queensland | |
| Novartis Investigative Site | Adelaide | South Australia | |
| Novartis Investigative Site | Parkville | Victoria | |
| Novartis Investigative Site | Roeselare | West-Vlaanderen | |
| Novartis Investigative Site | Edegem | Belgium | |
| Novartis Investigative Site | Leuven | Belgium | |
| Novartis Investigative Site | Belo Horizonte | Minas Gerais | |
| Novartis Investigative Site | Curitiba | Paraná | |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | |
| Novartis Investigative Site | São Paulo | São Paulo | |
| Novartis Investigative Site | São Paulo | São Paulo | |
| Novartis Investigative Site | Sao Jose Rio Preto | Brazil | |
| Novartis Investigative Site | Temuco | Chile | |
| Novartis Investigative Site | Beijing | Beijing Municipality | |
| Novartis Investigative Site | Beijing | Beijing Municipality | |
| Novartis Investigative Site | Guangzhou | Guangdong | |
| Novartis Investigative Site | Luoyang | Henan | |
| Novartis Investigative Site | Zhengzhou | Henan | |
| Novartis Investigative Site | Changsha | Hunan | |
| Novartis Investigative Site | Changchun | Jilin | |
| Novartis Investigative Site | Yinchuan | Ningxia |
+ 115 more sites — see the full list on the official registry below.
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04557462 on ClinicalTrials.gov ↗ ← All trials in Canada