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Набира участници Фаза 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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Primary IgA Nephropathy

Спонсор: Novartis Pharmaceuticals

Налично на: БГ
Обобщение
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.
Описание
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
Кой може да участва
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.
Места на провеждане 34
Argentina (1)
Novartis Investigative Site
Córdoba , Córdoba Province
ACTIVE_NOT_RECRUITING
Австралия (1)
Novartis Investigative Site
Woolloongabba , Queensland
ACTIVE_NOT_RECRUITING
Белгия (1)
Novartis Investigative Site
Roeselare , West-Vlaanderen
ACTIVE_NOT_RECRUITING
Бразилия (1)
Novartis Investigative Site
Belo Horizonte , Minas Gerais
ACTIVE_NOT_RECRUITING
Канада (1)
Novartis Investigative Site
Oshawa , Ontario
WITHDRAWN
Chile (1)
Novartis Investigative Site
Temuco
ACTIVE_NOT_RECRUITING
Китай (1)
Novartis Investigative Site
Beijing , Beijing Municipality
ACTIVE_NOT_RECRUITING
Colombia (1)
Novartis Investigative Site
Medellín , Antioquia
ACTIVE_NOT_RECRUITING
Чехия (1)
Novartis Investigative Site
Prague
ACTIVE_NOT_RECRUITING
Дания (1)
Novartis Investigative Site
Aalborg
ACTIVE_NOT_RECRUITING
Франция (1)
Novartis Investigative Site
Marseille
ACTIVE_NOT_RECRUITING
Hong Kong (1)
Novartis Investigative Site
Hong Kong , Hong Kong
ACTIVE_NOT_RECRUITING
Унгария (1)
Novartis Investigative Site
Pécs , Baranya
ACTIVE_NOT_RECRUITING
Индия (1)
Novartis Investigative Site
Bangalore , Karnataka
ACTIVE_NOT_RECRUITING
Израел (1)
Novartis Investigative Site
Ashkelon
ACTIVE_NOT_RECRUITING
Италия (1)
Novartis Investigative Site
Bologna , BO
ACTIVE_NOT_RECRUITING
Япония (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
Нидерландия (1)
Novartis Investigative Site
Groningen , Provincie Groningen
ACTIVE_NOT_RECRUITING
Норвегия (1)
Novartis Investigative Site
Nordbyhagen , Oslo
ACTIVE_NOT_RECRUITING
Russia (1)
Novartis Investigative Site
Rostov-on-Don
ACTIVE_NOT_RECRUITING
Сингапур (1)
Novartis Investigative Site
Singapore
ACTIVE_NOT_RECRUITING
Словакия (1)
Novartis Investigative Site
Košice
ACTIVE_NOT_RECRUITING
South Africa (1)
Novartis Investigative Site
Bloemfontein , Free State
ACTIVE_NOT_RECRUITING
Южна Корея (1)
Novartis Investigative Site
Bundang Gu , Gyeonggi-do
ACTIVE_NOT_RECRUITING
Испания (1)
Novartis Investigative Site
Pamplona , Navarre
ACTIVE_NOT_RECRUITING
Швеция (1)
Novartis Investigative Site
Stockholm
ACTIVE_NOT_RECRUITING
Taiwan (1)
Novartis Investigative Site
Kaohsiung City
ACTIVE_NOT_RECRUITING
Тайланд (1)
Novartis Investigative Site
Bangkok
ACTIVE_NOT_RECRUITING
Турция (1)
Novartis Investigative Site
Istanbul , Fatih
ACTIVE_NOT_RECRUITING
Великобритания (1)
Novartis Investigative Site
Newcastle upon Tyne , Tyne and Wear
ACTIVE_NOT_RECRUITING
САЩ (1)
AZ Kidney Dise and Hypertension Ctr
Glendale , Arizona
Vietnam (1)
Novartis Investigative Site
Ho Chi Minh City , VNM
ACTIVE_NOT_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
100 Years
Здрави доброволци
Не
Начална дата
20.09.2021
Крайна дата
25.10.2032
Регистрационен номер
NCT04557462
Източник
anzctr
Запитване за медицински туризъм

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