NCT04414735招募中不适用
Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients
Fundacion Clinic per a la Recerca Biomédica2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Time to first histological rejection in the first year of kidney transplantation.
研究概览
简要总结
The aim of the present study is to evaluate the superiority of photopheresis in combination with the standard immunosuppression vs standard immunosuppression alone for the prevention of acute rejection in highly sensitized kidney transplant recipients (cPRA ≥90%).
Unicentric, randomized, open study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sensitized (cPRA ≥90%) candidates for a deceased-donor kidney transplantation
- •Recipients between 18 and 75 years old
- •Patients are able to understand and sign informed consent (Annex 1).
排除标准
- •Participation in another interventional clinical trial.
- •Use of Rituximab or Eculizumab at the time of transplant or in the first 24 hours post-transplant.
- •Persons with any dependency on the researcher or employee by the responsible institution or researcher. As well as people detained by legal order.
结局指标
主要结局
Time to first histological rejection in the first year of kidney transplantation.
时间窗: 1 year after kidney transplantation
Time to first histological rejection in the first year of kidney transplantation.
次要结局
- Biopsy proved acute rejection(1 year after kidney transplantation)
- Glomerular filtrate rate at one year after kidney transplant(1 year after kidney transplantation)
研究者
Fritz Diekmann
Head of the Experimental Laboratory of Nephrology and Transplantation (LENIT)
Fundacion Clinic per a la Recerca Biomédica
研究点 (2)
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