A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporin Dose Reduction With Cyclosporin Elimination in de Novo Renal Allograft Recipients Receiving Rapamune

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 470 人开始时间: 2000年7月1日最近更新: 2010年3月10日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 470
主要终点: Kidney Function at 12 months after transplantation.

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 induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.

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

•Age: = to ≥ 18 years.
•End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor.
•Patients with second and subsequent transplants must have maintained their primary graft for at least 6 months after transplantation (with the exception of graft failure due to technical reasons).

排除标准

•Evidence of active systemic or localised major infection prior to initial Rapamune® administration.
•Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during screening.
•Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase. Exception: the use of erythropoiesis stimulating products. In these cases, erythrocyte-stimulating products must be discontinued prior to administration of Rapamune®.

结局指标

主要结局

Kidney Function at 12 months after transplantation.

次要结局

Kidney function at 6 months; incidence of side effects and rejection at 6 and 12 months.

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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