NCT00922129撤回2 期
A Prospective Randomized Pilot Study Examining the Role and Effectiveness of Conversion to Sirolimus Versus CNI Reduction in Renal Transplant Patients With Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Malignancy-free survival
研究概览
简要总结
The purpose of this study is to evaluate the role and effectiveness of conversion to sirolimus versus CNI reduction in renal transplant patients with prostate cancer.
详细描述
This study is designed to support the optimal use of mTOR-inhibitor by providing data for the safe and effectiveness use with sirolimus. This study will take into account effectiveness aspects such as malignancy-free survival cancer by reducing the overall exposure to calcineurin inhibitor.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients ≤ 50 years in their post renal transplant follow-up;
- •Biopsy confirmed prostate cancer;
- •Stable renal function with GFR ≥ 40 mL/min.
排除标准
- •Patients with metastatic disease;
- •Uncontrolled hyperlipidemia;
- •Proteinuria > 500 mg/day;
- •Biopsy evidence of acute rejection within the past 3 months;
- •Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication;
- •Patients with mental illness;
- •Inability to cooperate or communicate with the investigator or unable to complete self administered questionnaires.
研究组 & 干预措施
Conversion to sirolimus
Experimental
干预措施: Sirolimus (Rapamune) (Drug)
Calcineurim inhibitor reduction
Active Comparator
干预措施: Cyclosporin (Neoral) or Tacrolimus (Prograf) (Drug)
结局指标
主要结局
Malignancy-free survival
时间窗: Months 3, 9, 15, 21
次要结局
- Quality of life(Months 6, 12, 18 and 24)
- Renal function as measured by serum creatinine and calculated creatinine clearance (using the formula of Cockcroft-Gault)(Weeks 1, 3, 6, Months 3, 6, 9, 12, 15, 18, 21 and 24)
- Testosterone levels(Months 6, 12, 18 and 24)
研究者
研究点 (1)
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