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临床试验/NCT00225472
NCT00225472已完成1 期

Organ Preservation Media Investigation

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2004年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
2

研究概览

简要总结

Kidney transplantation remains limited by four problems: 1) a too high rate of delayed graft function, 2) early loss of kidneys from chronic rejection, 3) donor kidney shortages, and 4) the need for immunomodulating treatments. Improved cold storage methods can significantly impact on the first 3 of these 4 major problems. The device to be tested is a modification of the existing Viaspan organ preservation solution. The modification of this solution combines four compounds: Bovine neutrophil peptide-1 (BNP-1), Substance P (SP), Insulin-like growth factor-1 (IGF-1), and Nerve Growth Factor (NGF). This solution will be added to Viaspan for preservation of donor kidneys. Preclinical data indicates that trophic factor deprivation during cold storage is a significant and previously unrecognized mechanism of injury in cold stored kidneys. The aim of this study is improved graft function, decreasing early graft loss due to rejection, and decreasing the donor organ shortage.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

入选标准

  • first renal transplant, PRA's <20%

排除标准

  • PRA's greater than 20%
  • Subjects who are receiving a non-primary renal transplant
  • Subjects under the age of 18
  • Pregnant or nursing women

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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