Clinical trial NCT01450878: Renal Graft Function After Treatment With Erythropoietin (EPO)
Official title: Interest of a High Dose of Erythropoietin Administered During Graft Processing for Early Graft Outcome in Kidney Transplant Recipients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ischemia
Keywords: high dose of EPO
transplant kidney
cadaveric organ donor
mono-organ (kidney) retrieval
patient
kidney graft
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2011-10-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* donor:

  * 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%

Primary outcomes:
measure: a plasma creatinin level
timeFrame: 5 days
Secondary outcomes:
measure: The incidence of delayed graft function defined as follows:
timeFrame: 48 hours
measure: MDRD glomerular filtration rate at one and three months
timeFrame: three months
measure: The incidence of acute rejection during the first three months
timeFrame: three months
Other outcomes:
Locations:
city: Angers
country: France
facility: Néphrologie
city: Angers
country: France
facility: CHU d'ANGERS - CHPOT
city: Bordeaux
country: France
facility: CHU de BORDEAUX - CHPOT
city: Bordeaux
country: France
facility: CHU de BORDEAUX - Service de Néphrologie
city: Brest
country: France
facility: Néphrologie
city: Brest
country: France
facility: CHU de BREST - CHPOT
city: Limoges
country: France
facility: CHU de LIMOGES - CHPOT
city: Limoges
country: France
facility: CHU de LIMOGES - Service de Néphrologie
city: Nantes
country: France
facility: CHU de NANTES - CHPOT
city: Nantes
country: France
facility: CHU de NANTES - Service de Néphrologie
city: Poitiers
country: France
facility: Néphrologie
city: Poitiers
country: France
facility: CHU de POITIERS - CHPOT
city: Rennes
country: France
facility: CHU de RENNES - CHPOT
city: Rennes
country: France
facility: CHU de RENNES - Service de Néphrologie
city: Toulouse
country: France
facility: CHU de TOULOUSE - CHPOT
city: Toulouse
country: France
facility: CHU de TOULOUSE - Service de Néphrologie
city: Tours
country: France
facility: Néphrologie
city: Tours
country: France
facility: CHU de TOURS - CHPOT
Study officials:
affiliation: CHU LIMOGES
name: Marie ESSIG, MD
role: PRINCIPAL_INVESTIGATOR
References: