NCT00505102Unknown4 期
Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients
A.O. Ospedale Papa Giovanni XXIII2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin
研究概览
简要总结
The purpose of this study is to verify whether the reduction of cyclosporine dosages associated with Everolimus administration may improve renal function as compared to patients maintained on standard immunosuppressive therapy
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart Transplant patients with more than 1 year of follow-up
- •Creatinine lower than 3.5 mg/dl
- •GFR Higher than 20 ml/min (calculated with Cockcroft-Gault formula)
- •Cyclosporine in maintenance immunosuppressive therapy
- •Patient must be able to sign an approve informed consent
- •Prior History of acute rejection within the last 3 months
- •Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used
排除标准
- •Patients who are recipients of multiple organ transplants
- •Prior or current use of sirolimus or everolimus
- •History of acute rejection within the last 6 months
- •Coronary Artery Bypass Surgery or other cardiac surgery in the past 3 months
- •Patient not able to attend all follow-up evaluations
研究组 & 干预措施
A
Active Comparator
干预措施: Everolimus (Drug)
结局指标
主要结局
Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin
时间窗: 2 years
次要结局
- All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace(2 years)
研究者
研究点 (2)
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