Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy

Wyeth is now a wholly owned subsidiary of Pfizer13 个研究点分布在 1 个国家目标入组 100 人开始时间: 2006年8月1日最近更新: 2007年3月22日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 100
试验地点: 13
主要终点: Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Renal transplantation
•Biopsy-confirmed chronic rejection
•Treatment with mofetil mycophenolate among cyclosporine or tacrolimus

排除标准

•Transplant of any organ other than the kidney
•Current important infection
•Acute rejection within 12 weeks prior to inclusion

结局指标

主要结局

Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus

次要结局

Histological parameters at 12 months
Cumulative incidence of biopsy-confirmed acute rejection at 12 months
Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

研究点 (13)

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