Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Number of kidney allograft during the 2 years post-transplantation
研究概览
简要总结
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.
详细描述
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 :
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Number of kidney allograft during the 2 years post-transplantation
时间窗: 24 months
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.
Exposure to calcineurin inhibitors (mean tacrolimus level) between month 6 and month 24 post-transplantation.
时间窗: 24 months
To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors.
次要结局
- Number of participants with adverse events as assessed by CTCAE v4.0 in each group(24 months)
- Cost-utility(24 months)
- Allograft fibrosis on the surveillance biopsy at 24 months(24 months)
- Allograft function (estimated Glomerular Filtration Rate) at 24 months(24 months)
- Predicted allograft survival until 10 years after evaluation(10 years)