A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation

Официальное название

A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients

Обзор

The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing kidney transplantation. Participants aged 18 to 70 years who have low-to-moderate immunologic risk of graft rejection and receive their first kidney transplant are eligible if they meet all inclusion and no exclusion criteria. Study details include: * The study and treatment duration will be up to approximately 5 years. * The number of visits will be approximately 38.

Вмешательства

• Препарат Frexalimab
  Pharmaceutical form:Solution for injection-Route of administration:IV
• Препарат Frexalimab
  Pharmaceutical form:Solution for injection-Route of administration:SC
• Препарат Tacrolimus
  Pharmaceutical form:Capsule-Route of administration:Oral
• Препарат rabbit anti-thymocyte globulin
  Pharmaceutical form:Solution for injection-Route of administration:IV
• Препарат mycophenolate mofetil
  Pharmaceutical form:Tablet or capsule-Route of administration:Oral
• Препарат mycophenolate sodium
  Pharmaceutical form:Tablet-Route of administration:Oral
• Препарат methylprednisolone
  Pharmaceutical form:Solution for injection-Route of administration:IV
• Препарат prednisone
  Pharmaceutical form:Tablet-Route of administration:Oral

Первичные конечные точки

• Composite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation [Срок оценки: by 1 year]

Вторичные конечные точки (12)

• eGFR at 1 year post kidney transplantation [Срок оценки: at 1 year]
• eGFR at 6 months, 2 years, 3 years, 4 years, and 5 years post kidney transplantation [Срок оценки: at 6 months, 2 years, 3 years, 4 years, and 5 years]
• Change of eGFR from Month 3 over time up to 5 years post kidney transplantation [Срок оценки: from Month 3 over time up to 5 years]
• Participant status of eGFR > 60 mL/min/1.73 m2 at 1, 2, 3, and 5 years post kidney transplantation [Срок оценки: at 1, 2, 3, and 5 years]
• Participant status of eGFR < 60 mL/min/1.73 m² at Month 12 or with a > 10 mL/min/1.73 m² decrease in eGFR from Month 3 to 12 [Срок оценки: from Month 3 to 12]
• Proteinuria at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation [Срок оценки: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
• iBox score at 1 year post kidney transplantation [Срок оценки: at 1 year]
• Composite of participant and graft survival at 5 years post kidney transplantation [Срок оценки: at 5 years]
• Composite of participant and graft survival over time and at 6 months, 1 year, 2 years, 3 years, and 4 years post kidney transplantation [Срок оценки: at 6 months, 1 year, 2 years, 3 years, and 4 years]
• Death-censored graft survival over time and at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation (including the causes of graft loss) [Срок оценки: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
• Participant survival over time and at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation (including the causes of death) [Срок оценки: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years]
• Incidence of BPAR (yearly and cumulative) up to 5 years post kidney transplantation [Срок оценки: up to 5 years]

Критерии участия

Критерии включения

• Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
• Participants with low to moderate immunological risk.

Критерии исключения

• Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac death.
• Positive T or B cell crossmatch, or positive virtual crossmatch per local practice at screening.
• Participants receiving a kidney graft from HLA-identical living-related donors, or have current or previous solid organ, cell, or multi-organ transplantation, or paired kidney transplantation.
• Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy
• Evidence of active or latent TB, HIV, HBV or HCV infection.
• Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy.
• Participants who have severe medical co-morbidities, active infection, or severely limited life expectancy due to underlying medical conditions that are generally precluded from kidney transplant.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 9 центров

• Investigational Site Number : 1560003 — Чэнду
• Investigational Site Number : 1560012 — Цзинань
• Investigational Site Number : 1560017 — Nanchang
• Investigational Site Number : 1560008 — Nanning
• Investigational Site Number : 1560001 — Шанхай
• Investigational Site Number : 1560011 — Тяньцзинь
• Investigational Site Number : 1560006 — Ухань
• Investigational Site Number : 1560005 — Чжэнчжоу
• … и ещё 1 центр

Испания · 4 центра

• Investigational Site Number : 7240001 — Barcelona
• Investigational Site Number : 7240007 — Barcelona
• Investigational Site Number : 7240003 — L'Hospitalet de Llobregat
• Investigational Site Number : 7240005 — Málaga

Австралия · 3 центра

• Investigational Site Number : 0360002 — Adelaide
• Investigational Site Number : 0360001 — Parkville
• Investigational Site Number : 0360003 — Sydney

США · 2 центра

• Brigham & Women's Hospital- Site Number : 8400049 — Boston
• Montefiore Medical Center - Moses Campus- Site Number : 8400006 — The Bronx

Чили · 2 центра

• Investigational Site Number : 1520005 — Santiago
• Investigational Site Number : 1520004 — Santiago

Аргентина · 1 центр

• Investigational Site Number : 0320001 — Corrientes

Бельгия · 1 центр

• Investigational Site Number : 0560002 — Brussels

Дания · 1 центр

• Investigational Site Number : 2080001 — Aarhus

Израиль · 1 центр

• Investigational Site Number : 3760002 — Ramat Gan

Италия · 1 центр

• Центр не указан — Torette

Великобритания · 1 центр

• Investigational Site Number : 8260001 — Birmingham

Идентификаторы

NCT: NCT07412470 · EFC18554 · 2025-521521-33-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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