NCT01269684撤回4 期
A 6-Month Open Pilot Study to Investigate the Safety and Tolerability of Immediate Conversion From Calcineurin Inhibitor Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Routine safety laboratory
研究概览
简要总结
The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients.
Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml
干预措施: Everolimus (Drug)
结局指标
主要结局
Routine safety laboratory
时间窗: Month 6
次要结局
- renal function(Months 1, 2, 4 and 6)
研究者
研究点 (1)
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