Ischemia Clinical Trial
Official title:
Interest of a High Dose of Erythropoietin Administered During Graft Processing for Early Graft Outcome in Kidney Transplant Recipients.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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