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临床试验/NCT00167791
NCT00167791撤回不适用

Multicenter Trial Using Multi-dose Rituximab as Induction and Desensitization Therapy for Patients on the Waiting List for Kidney Transplant With a Positive Donor Specific Crossmatch to a Living Donor

University of Wisconsin, Madison2 个研究点 分布在 1 个国家开始时间: 2005年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful transplantation.

研究概览

简要总结

This is a study of patients who have a high risk of kidney rejection before kidney transplant. The hypothesis is that treatment with a medication called rituximab will make it possible for them to receive a kidney transplant from a donor who previously did not present a good match.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
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

  • Active status on a kidney transplant waiting list with positive cross match against a living donor

排除标准

  • Receipt of a live vaccine within 4 weeks prior to randomization
  • Previous Treatment with Rituximab

结局指标

主要结局

Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful transplantation.

时间窗: assess 4 weeks after Rituximab treatment completed

Transplant success or failure following the desensitization protocol.

时间窗: ongoing assessment for 2 years after transplant

次要结局

  • Decrease in incidence of humoral rejection to less than 50% at 1 year.(assess 1 year after transplant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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