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
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
- 否
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
研究点 (2)
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