A One-year Multicenter, Randomized, Open-label Study of the Safety and Efficacy of Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

Novartis Pharmaceuticals1 个研究点分布在 1 个国家开始时间: 2004年8月最近更新: 2016年11月18日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis Pharmaceuticals
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microemulsion are compared in maintenance heart transplant recipients with impaired renal function.

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

•Recipients of primary heart transplant
•Reduced renal function (serum creatinine > 1.7 ng/mL over 2 months or more) at 6 months or more after heart transplantation
•Patients with current immunosuppressive therapy consisting of cyclosporine microemulsion and mycophenolate mofetil

排除标准

•Patients who are recipients of multiple organ transplants
•Patients who have previously received an organ transplant
•Patients with serum creatinine > 3.5 mg/dl
•Other protocol-defined exclusion criteria may apply.

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

研究点 (1)

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