NCT00157300已完成4 期
PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- incidence of delayed graft function and primary non function after kidney transplantation
研究概览
简要总结
Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation.
The investigators postulate that erythropoietin reduces the risk of delayed graft function.
详细描述
Randomized, double blind, placebo controlled, prospective trial in patients, receiving a kidney transplantation. Patients will be randomized to receive either Epoetin Beta (Neorecormon; Roche) or placebo.
The primary endpoint will be delayed graft function. The anticipated duration of this trial is 2 year and the target sample size is 60 patients per arm.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Receiving a kidney from a non-heart-beating donor category 3
排除标准
- •Donor related factors: a prolonged warm ischaemic time (> 45 min); a cold ischaemic time of > 24 hours; serum creatinin of > 150 umol/l
研究组 & 干预措施
Epoetin beta
Experimental
干预措施: Epoetin beta (Drug)
结局指标
主要结局
incidence of delayed graft function and primary non function after kidney transplantation
时间窗: within12 weeks after transplantation
次要结局
- incidence of acute rejection episodes(till one year after transplantation)
- renal function at 3, 6 and 12 months(3, 6 and 12 months after transplantation)
- patient and graft survival(one year)
- duration of dialysis treatment(within 12 weeks after transplantation)
研究者
研究点 (2)
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