跳至主要内容
临床试验/NCT01285375
NCT01285375Unknown1 期

Safety and Preliminary Efficacy of the Treatment of Kidney Allografts With Curcumin-containing Preservation Solution

Helsinki University Central Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
1 期
入组人数
20
试验地点
2
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

入选标准

  • Patients with ESRD assigned for kidney transplantation, written informed consent

排除标准

  • 未提供

结局指标

主要结局

Delayed Graft Function

时间窗: 7 days

次要结局

  • Graft function eGFR(30 days, 90 days)
  • Primary non-function(1 year)
  • Acute rejection(1 year)
  • Graft Survival(1 year)
  • Patient Survival(1 year)
  • Length of stay in hospital(upto 1 year)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验