NCT00195481已完成4 期
A Post Marketing Surveillance Looking at Safety of Rapamune (Sirolimus) in Indian Population Undergoing de Novo Renal Transplantation.
Wyeth is now a wholly owned subsidiary of Pfizer5 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2004年4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
- 100
- 试验地点
- 5
- 主要终点
- Safety evaluation
研究概览
简要总结
To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.
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
- 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 in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms.
- •Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor.
排除标准
- •Evidence of major infections at the time of sirolimus administration
- •Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the treatment phase.
- •Females who are pregnant, breast feeding or in reproductive age group and not using a medically acceptable form of contraception
结局指标
主要结局
Safety evaluation
次要结局
未报告次要终点
研究者
研究点 (5)
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