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Recruiting Phase 3 NCT04557462

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

Phase 3 – large-scale trial before approval
Conditions: Primary IgA Nephropathy

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
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.
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
Who can participate
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.
Locations 34
Argentina (1)
Novartis Investigative Site
Córdoba , Córdoba Province
ACTIVE_NOT_RECRUITING
Australia (1)
Novartis Investigative Site
Woolloongabba , Queensland
ACTIVE_NOT_RECRUITING
Belgium (1)
Novartis Investigative Site
Roeselare , West-Vlaanderen
ACTIVE_NOT_RECRUITING
Brazil (1)
Novartis Investigative Site
Belo Horizonte , Minas Gerais
ACTIVE_NOT_RECRUITING
Canada (1)
Novartis Investigative Site
Oshawa , Ontario
WITHDRAWN
Chile (1)
Novartis Investigative Site
Temuco
ACTIVE_NOT_RECRUITING
China (1)
Novartis Investigative Site
Beijing , Beijing Municipality
ACTIVE_NOT_RECRUITING
Colombia (1)
Novartis Investigative Site
Medellín , Antioquia
ACTIVE_NOT_RECRUITING
Czech Republic (1)
Novartis Investigative Site
Prague
ACTIVE_NOT_RECRUITING
Denmark (1)
Novartis Investigative Site
Aalborg
ACTIVE_NOT_RECRUITING
France (1)
Novartis Investigative Site
Marseille
ACTIVE_NOT_RECRUITING
Hong Kong (1)
Novartis Investigative Site
Hong Kong , Hong Kong
ACTIVE_NOT_RECRUITING
Hungary (1)
Novartis Investigative Site
Pécs , Baranya
ACTIVE_NOT_RECRUITING
India (1)
Novartis Investigative Site
Bangalore , Karnataka
ACTIVE_NOT_RECRUITING
Israel (1)
Novartis Investigative Site
Ashkelon
ACTIVE_NOT_RECRUITING
Italy (1)
Novartis Investigative Site
Bologna , BO
ACTIVE_NOT_RECRUITING
Japan (1)
Novartis Investigative Site
Kasugai , Aichi-ken
ACTIVE_NOT_RECRUITING
Malaysia (1)
Novartis Investigative Site
Kuala Lumpur , Kuala Lumpur
ACTIVE_NOT_RECRUITING
Mexico (1)
Novartis Investigative Site
Mexico City
Netherlands (1)
Novartis Investigative Site
Groningen , Provincie Groningen
ACTIVE_NOT_RECRUITING
Norway (1)
Novartis Investigative Site
Nordbyhagen , Oslo
ACTIVE_NOT_RECRUITING
Russia (1)
Novartis Investigative Site
Rostov-on-Don
ACTIVE_NOT_RECRUITING
Singapore (1)
Novartis Investigative Site
Singapore
ACTIVE_NOT_RECRUITING
Slovakia (1)
Novartis Investigative Site
Košice
ACTIVE_NOT_RECRUITING
South Africa (1)
Novartis Investigative Site
Bloemfontein , Free State
ACTIVE_NOT_RECRUITING
South Korea (1)
Novartis Investigative Site
Bundang Gu , Gyeonggi-do
ACTIVE_NOT_RECRUITING
Spain (1)
Novartis Investigative Site
Pamplona , Navarre
ACTIVE_NOT_RECRUITING
Sweden (1)
Novartis Investigative Site
Stockholm
ACTIVE_NOT_RECRUITING
Taiwan (1)
Novartis Investigative Site
Kaohsiung City
ACTIVE_NOT_RECRUITING
Thailand (1)
Novartis Investigative Site
Bangkok
ACTIVE_NOT_RECRUITING
Turkey (1)
Novartis Investigative Site
Istanbul , Fatih
ACTIVE_NOT_RECRUITING
United Kingdom (1)
Novartis Investigative Site
Newcastle upon Tyne , Tyne and Wear
ACTIVE_NOT_RECRUITING
United States (1)
AZ Kidney Dise and Hypertension Ctr
Glendale , Arizona
Vietnam (1)
Novartis Investigative Site
Ho Chi Minh City , VNM
ACTIVE_NOT_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
20.09.2021
Completion date
25.10.2032
Registry ID
NCT04557462
Source
anzctr
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