NCT00716573已完成4 期
COREV : A Multi-center, Randomized, Open-label Study Evaluating the Efficacy on Renal Function of Everolimus in Heart Transplant Recipients With Established Chronic Renal Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease.
研究概览
简要总结
After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduction of everolimus. The risk or benefits of these strategies were not clearly evaluated by specific clinical trials.
This study is specifically designed for evaluating the impact of everolimus introduction, with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and clinical outcomes, specially on :
- Renal function improvement
- Vasculopathy and major cardiac event reduction
- Maintenance of immunosuppressive efficacy
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
- •Male or female cardiac recipients over 18 years old
- •First or second heart transplant, more than one year following surgery
- •Patients with renal failure assessed by cGFR 30 to 60 ml/min/1,73m² calculated by MDRD4 formula
- •Patients volunteer to participate in the study, with a written informed consent signed
- •Affiliation to a national health insurance program
排除标准
- •Current CNI-free immunosuppressive regimen
- •Patients currently or previously treated with a mTOR inhibitor any time prior randomization
- •Patients who are recipients for a multiple solid organ transplant
- •Treated acute rejection episode within three months prior randomization
- •Congestive heart failure (NYHA class III or IV) and/or VEF < 30 % and/or patient waiting for a re-transplantation
- •Scheduled surgical intervention
- •Platelet count < 50 G/l
- •Severe hepatic insufficiency (SGPT and/or SGOT > 3N)
- •Major lipidic profile abnormalities (total cholesterol > 3g/l and/or TG > 5g/l)
- •Proteinuria/creatinuria > 0,08 g/mmol
- •Severe renal failure attested by cGFR < 30 ml/min/1.73m² (MDRD4)
- •History of Hypersensitivity to everolimus, sirolimus or excipients
- •History of Hypersensitivity to macrolides
- •Pregnancy and breast feeding
- •Childbearing age women without efficient contraception
- •Law protected patients
- •Patients in emergency unable to express their consent
- •History of Hypersensitivity to cyclosporine or St-John's wort, stiripentol, bosentan, rosuvastatin
- •History of Hypersensitivity to tacrolimus, macrolides or excipients
- •History of Hypersensitivity to azathioprine
- •History of Hypersensitivity to mycophénolate mofetil or excipients
研究组 & 干预措施
1
Experimental
Introduction of everolimus associated with CNI (ciclosporin or tacrolimus) reduction (50%) to the current immunosuppression schedule
干预措施: everolimus (Drug)
结局指标
主要结局
Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease.
时间窗: 12 months
次要结局
- Evaluation of the benefit of everolimus introduction on renal function at 24 months(24 months)
- Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals(24 months)
- Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria)(24 months)
- Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection(24 months)
- Evaluation of the benefit of everolimus introduction on safety(24 months)
- Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs)(24 months)
研究者
研究点 (1)
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