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 UK tracker

Sponsor

Novartis Pharmaceuticals

Phase

Phase 3

Started

2021-09-20

Last updated

2026-07-30

Condition(s) studied

Primary IgA Nephropathy

Investigational drug(s) / intervention(s)

LNP023

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

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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
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

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression Active, not recruiting

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 the UK