Interest of a High Dose of Erythropoietin Administered During Graft Processing for Early Graft Outcome in Kidney Transplant Recipients.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 15
- 主要终点
- a plasma creatinin level
研究概览
简要总结
Background : Numerous studies have outlined the cellular pleiotropic effects of erythropoietin (EPO) and their role in the prevention of ischemic-reperfusion lesion such as after acute ischemic injury of the brain or the heart. However, most of these studies were carried out in animal models and no definitive proof exists today to demonstrate that EPO has similar beneficial effects in human pathology.
Purpose : The aim of the study is to demonstrate that in humans, EPO can protect against ischemic-reperfusion lesions in a model of ischemia i.e. kidney transplantation.
详细描述
Abstract : Since the discovery that EPO and its receptor are expressed in various tissues, numerous studies have demonstrated that EPO is not only involved in erythropoiesis but also exerts pleiotropic effects on cells. Among these, one of the most exciting is its role in the prevention of ischemic-reperfusion lesions such as after acute ischemic injury of the brain or the heart. However, most of these studies were carried out in animal models and no definitive proof exists today to demonstrate that EPO has similar beneficial effects in human pathology. Kidney transplantation is one ischemic situation where EPO pleiotropic effects could be of great interest since ischemic-reperfusion lesions have been involved in delayed graft function and impaired graft outcomes.
The aim of this prospective randomized double blind study is to assess the effect of 100 000 UI of béta-epoiétin on kidney graft function, given to the deceased donor one hour before the retreaval of the organ. Recipients will be followed for three months in order to evaluate kidney function (glomerular filtration rate) and the number of acute rejection episodes to determine whether beta-epoietin could modify the immunogenicity of the graft.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cadaveric organ donor,
- •age ≥ 18 years,
- •mono-organ (kidney) retrieval,
- •retrieval done in the centres of Limoges, Bordeaux, Toulouse, Angers, Brest, Nantes, Poitiers, Rennes, Tours,
- •hematocrit ≤ 45%.
- •Recipient:
- •age ≥ 18 years,
- •on the waiting list for a kidney graft.
排除标准
- •living donors,
- •age under 18 years,
- •multi-organ retrieval,
- •donor hematocrit above 45%
研究组 & 干预措施
Graft with EPO
intravenous 1000 000UI beta-epoietin one hour before organe retrieval.
干预措施: beta-epoietin (Drug)
结局指标
主要结局
a plasma creatinin level
时间窗: 5 days
To assess the effect of an injection of 100 000 UI of beta-epoitein during graft processing, on the proportion of renal recipients with a plasma creatinin level below 250 µM at day 5 after transplantation in the absence of hemodialysis, death or transplantectomy.
次要结局
- The incidence of acute rejection during the first three months(three months)
- The incidence of delayed graft function defined as follows:(48 hours)
- MDRD glomerular filtration rate at one and three months(three months)