Clinical Impact of the IBox As an Early Intervention TooL: a Prospective Randomised Controlled Trial to Assess the Use of a Software Predicting Allograft Survival in the Follow-up of Kidney Transplanted Patients.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 507
- 试验地点
- 32
- 主要终点
- number of biopsies leading to therapeutic change
研究概览
简要总结
International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.
详细描述
The study aims to demonstrate improvement of the prevalence of biopsies leading to therapeutic change in the Predigraft group compared to the Standard of care group in kidney transplanted patients.
It is hypothesized that using Predigraft as a monitoring tool will help the physician detect earlier and more often abnormalities with the patient allograft. This should lead to an increased number of biopsies leading to therapeutic change. These biopsies should be performed earlier than without the iBox monitoring tool. This would improve long-term allograft function, kidney allograft and patient survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, age ≥ 18 years old at the time of consent.
- •Patients receiving a living or deceased donor kidney allograft.
- •Patients transplanted at least 3 months before inclusion.
- •Patients who signed the informed consent form and are willing to comply with study procedures.
排除标准
- •Combined transplant (i.e. heart-kidney, liver-kidney).
- •Patients who are unable or unwilling to comply with study procedures.
- •Vulnerable patients (minors, protected adults, legally detained).
- •Patients participating in other interventional studies.
结局指标
主要结局
number of biopsies leading to therapeutic change
时间窗: 18 months
number of biopsies leading to therapeutic change by the end of the follow-up (18 months).
次要结局
- iBox predicted allograft survival(18 months)
- Number of therapeutic changes(18 months)
- Patient outcome(18 months)
- Lapse of time between the detection of kidney allograft instability and the biospy(18 months)
- Renal function(18 months)
- Number of unnecessary biopsies(18 months)