Interest of a High Dose of Erythropoietin Administered During Graft Processing for Early Graft Outcome in Kidney Transplant Recipients.
Overview
- Phase
- Phase 3
- Intervention
- beta-epoietin
- Conditions
- Ischemia
- Sponsor
- University Hospital, Limoges
- Enrollment
- 6
- Locations
- 15
- Primary Endpoint
- a plasma creatinin level
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •living donors,
- •age under 18 years,
- •multi-organ retrieval,
- •donor hematocrit above 45%
Arms & Interventions
Graft with EPO
intravenous 1000 000UI beta-epoietin one hour before organe retrieval.
Intervention: beta-epoietin
Outcomes
Primary Outcomes
a plasma creatinin level
Time Frame: 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.
Secondary Outcomes
- 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)