Rapamycin Use in CNI-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Renal function after 6 months (serum creatinine, calculated creatinine clearance)
研究概览
简要总结
Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity?
Study Design: Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression.
Read-Out: Renal function after 6 months; tolerability; and safety were assessed.
详细描述
Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity?
Study Design: Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression.
Read-Out: Renal function after 6 months; tolerability; and safety were assessed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart transplantation (> 6 months post-operation)
- •Renal failure (serum creatinine stably > 1.7 mg/dl
- •Cyclosporine trough blood level < 110 ng/ml
排除标准
- •< 18 years of age
- •Rapamycin intolerability
- •Active infection
- •Pregnancy, breast feeding
- •Major elective surgery planned in study period
- •Thrombopenia < 100,000/ml
结局指标
主要结局
Renal function after 6 months (serum creatinine, calculated creatinine clearance)
次要结局
- Survival
- Rejection (clinical)
- Tolerability
- Blood pressure