NCT00133887已完成3 期
Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-label Study of Rapamycin vs Calcineurin Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- To assess the incidence of new squamous cell carcinoma in kidney transplant recipients
研究概览
简要总结
In a population of kidney transplant recipients having developed a first squamous cell carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2 years in patients who are switched to rapamycin as compared to patients who are maintained under calcineurin inhibitors.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First post-transplant squamous cell carcinoma in a kidney transplant recipient under calcineurin inhibitors
排除标准
- •Other squamous cell carcinomas in the past history
- •More than 2 transplantations
- •Patients not under calcineurin inhibitors
- •Unstable graft function
- •Non controlled hyperlipidemia (cholesterol > 7.8 mmol/l or triglycerides > 3.95 mmol/l)
- •Leucopenia < 3000/mm3
- •Thrombocytopenia < 100,000/mm3
- •Liver dysfunction
- •Pregnancy
- •Allergy to macrolides
研究组 & 干预措施
1
Experimental
patients receiving Rapamycin
干预措施: rapamycin (Drug)
2
Active Comparator
patients receiving anticalcineurin treatment
干预措施: ciclosporine (Drug)
2
Active Comparator
patients receiving anticalcineurin treatment
干预措施: tacrolimus (Drug)
结局指标
主要结局
To assess the incidence of new squamous cell carcinoma in kidney transplant recipients
时间窗: during 5 years
次要结局
- To assess the incidence of other non skin cancer in kidney transplant recipients(during 5 years)
- To assess the graft survival(during 5 years)
- To assess the tolerance of rapamycin(during 5 years)
研究者
研究点 (1)
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