An Open-Label, Concentration-Controlled, Randomized, 12-Month Study of Prograf + Rapamune + Corticosteroids Compared to Cyclosporine,USP (Modified) + Rapamune + Corticosteroids in High Risk Renal Allograft Recipients

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 460 人开始时间: 2002年8月1日最近更新: 2007年5月8日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 460
主要终点: First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following 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

The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
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

•Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor.
•Age >= 13 years, weight >= 40 kg
•Women must have a negative pregnancy test at study entry

排除标准

•Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult)
•Active systemic infection, or localized major infection or known HIV
•Patients with residual kidney function >20 mL/min

结局指标

主要结局

First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation.

次要结局

未报告次要终点

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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