A Randomized, Open-Label Study of Continuous Therapy With Cyclosporine and Sirolimus Versus Induction With Cyclosporine and Sirolimus Followed by Continuous Therapy With Sirolimus in Renal Allograft Recipients

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 408 人开始时间: 1998年5月1日最近更新: 2007年1月29日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 408
主要终点: Equivalence of graft survival at month 12

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.

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: 13 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor.
•Women who are of childbearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of sirolimus

排除标准

•Evidence of active systemic or localized major infection at the time of initial sirolimus administration
•Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
•Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery

结局指标

主要结局

Equivalence of graft survival at month 12

次要结局

Renal function; biopsy-confirmed acute rejection, grade of acute rejection; subject and graft survival; incidence of infection, malignancy, treatment failure, and of chronic rejection as determined by protocol biopsies; quality of life.

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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