NCT00420537终止4 期
Safety and Efficacy of Low-dose Cyclosporine in Association With Everolimus to Minimize Renal Dysfunction in Heart Transplant Recipients
University of Bologna1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2006年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Calculated GFR
研究概览
简要总结
The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 Transplant with 1 to 4 years of follow-up
- •GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula)
排除标准
- •Acute rejection in the previous 6 months
- •Contraindications to statin therapy
- •Ongoing infection
- •Ongoing heart failure
- •Myocardial infarction or myocardial revascularization after transplant
- •Malignancy
研究组 & 干预措施
mycophenolate
Active Comparator
Mycophenolate mofetil with cyclosporine trough levels between 100 and 150
干预措施: cyclosporine (Drug)
mycophenolate
Active Comparator
Mycophenolate mofetil with cyclosporine trough levels between 100 and 150
干预措施: Mycophenolate mofetil (Drug)
Everolimus
Active Comparator
Everolimus with cyclosporine trough levels between 40 and 90 ng/ml
干预措施: cyclosporine (Drug)
Everolimus
Active Comparator
Everolimus with cyclosporine trough levels between 40 and 90 ng/ml
干预措施: Everolimus (Drug)
结局指标
主要结局
Calculated GFR
时间窗: One year after randomization
次要结局
未报告次要终点
研究者
研究点 (1)
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