Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study

Обзор

Currently, the monitoring of children receiving a kidney transplantation includes surveillance biopsies to detect subclinical rejection and signs of toxicity of immunosuppressive drugs (tacrolimus). The hypothesis of the study is that the combination of non-invasive biomarkers (Donor-derived cell-free DNA and Virus-specific T cells) will allow both the safe discontinuation of surveillance biopsies and the personalization of the exposure to calcineurin inhibitors among pediatric kidney transplant recipients.

Подробное описание

MONITOR is an open label multicenter prospective randomized trial of superiority with two active comparators (4 parallel groups 1:1:1:1).

Arm A: monitoring by dd-cfDNA; Arm B: monitoring by T-Vis; Arm C: monitoring by dd-cfDNA+ T-Vis; Comparator arm: Current standard of care based on surveillance biopsies and biological monitoring

Main objectives and primary endpoints :

1. To demonstrate that the use of an integrative score of allograft rejection including dd-cfDNA measurement allows the reduction of the number of surveillance biopsies.

Endpoint: Number of biopsy performed in each arm 2. To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors.

Endpoint: Tacrolimus exposure assessed as the mean of the residual concentration of Tacrolimus between M6 and M24

Вмешательства

• Процедура monitoring by dd-cfDNA
  monitoring by dd-cfDNA
• Процедура monitoring by T-Vis
  monitoring by T-Vis
• Процедура monitoring by dd-cfDNA+ T-Vis
  monitoring by dd-cfDNA+ T-Vis

Первичные конечные точки

• Number of kidney allograft during the 2 years post-transplantation [Срок оценки: 24 months]
• Exposure to calcineurin inhibitors (mean tacrolimus level) between month 6 and month 24 post-transplantation. [Срок оценки: 24 months]

Вторичные конечные точки (5)

• Number of participants with adverse events as assessed by CTCAE v4.0 in each group [Срок оценки: 24 months]
• Cost-utility [Срок оценки: 24 months]
• Allograft fibrosis on the surveillance biopsy at 24 months [Срок оценки: 24 months]
• Allograft function (estimated Glomerular Filtration Rate) at 24 months [Срок оценки: 24 months]
• Predicted allograft survival until 10 years after evaluation [Срок оценки: 10 years]

Критерии участия

Критерии включения

• Age less than 21 years old at transplantation
• Single renal transplant from a deceased or a living donor.
• Absence of pregnancy confirmed by a negative pregnancy test in women in child-bearing period.
• Subject and legal guardians are willing and able to provide signed written informed consent and to comply with the study procedures
• Patients affiliated to health insurance system including Aide Médicale de l'Etat (AME)

Критерии исключения

• History of multi-organ transplant (interference with rejection natural history)
• No surveillance biopsy planned
• Adult patient (or legal guardians) with limited understanding of the French language preventing him from receiving informed information on the protocol

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

Другое

Центры проведения

Франция · 1 центр

• Robert Debré Hospital — Paris

Идентификаторы

NCT: NCT06761482 · APHP230817 · IDRCB 2024-A01418-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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