NCT00254709已完成4 期
Open, Pilot, Comparative Study to Evaluate the Efficacy and Safety of Two Immunosuppressor Regimens, Anti Il-2, Sirolimus Mycophenolate, Mophetyl and Steroids Versus Sirolimus, Cyclosporine, and Withdrawal of Cyclosporine Since the Third Month and Steroids in Elderly Population
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 66 人开始时间: 2002年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 主要终点
- Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine
研究概览
简要总结
The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage renal disease
- •Kidney transplantation
- •Both donor and recipient older than 60 years
排除标准
- •Prior or concurrent transplant of any organ other than the kidney
- •Current clinically significant infections
结局指标
主要结局
Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine
次要结局
- Time to recover renal function (creatinine< 2 mg/dl)
- Incidence of acute rejections at 3 and 12 months
- Patient and graft survival at 3 and 12 months
- Incidence and duration of episodes of acute tubular necrosis
研究者
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