NCT00214201已完成不适用
Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Biopsy Proven Rejection
研究概览
简要总结
The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •received a renal transplant, induction with Campath-1H, and at least 2 months of calcineurin inhibitor therapy, CellCept, and prednisone.
排除标准
- •Recipients of HLA-identical living-donor renal transplants;
- •PRA value >20% within 30 days of transplant;
- •GFR <40ml/min;
- •multi-organ transplant;
研究组 & 干预措施
2
Experimental
Calcineurin inhibitor withdrawal
干预措施: Calcineurin inhibitor withdrawal (Drug)
结局指标
主要结局
Number of Participants With Biopsy Proven Rejection
时间窗: 3 years
次要结局
- Serum Creatinine at 36 Months (End of Study)(36 months +/- 60 days)
研究者
研究点 (1)
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