NCT01285375Unknown1 期
Safety and Preliminary Efficacy of the Treatment of Kidney Allografts With Curcumin-containing Preservation Solution
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Delayed Graft Function
研究概览
简要总结
The safety and preliminary efficacy of the addition of an aqueous curcumin-cyclodextrin complex (CDC) solution to graft perfusion solution is studied. CDC has proved safe and highly effective in preventing primary graft non-function, delayed graft function and chronic dysfunction in pre-clinical kidney transplantation animal models. The hypothesis is that addition of CDC to the graft perfusion solution will decrease the incidence of delayed graft function in human kidney transplantation subjects.
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
- •Patients with ESRD assigned for kidney transplantation, written informed consent
排除标准
- 未提供
研究组 & 干预措施
CDC graft perfusion
Active Comparator
Flushing of kidney allografts prior to transplantation with UW-solution containing CDC
干预措施: CDC solution (Device)
Sham perfusion
Sham Comparator
干预措施: UW-solution (Device)
结局指标
主要结局
Delayed Graft Function
时间窗: 7 days
次要结局
- Primary non-function(1 year)
- Acute rejection(1 year)
- Graft function eGFR(30 days, 90 days)
- Graft Survival(1 year)
- Patient Survival(1 year)
- Length of stay in hospital(upto 1 year)
研究者
研究点 (1)
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