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Renal Graft Function After Treatment With Erythropoietin (EPO) (FRETEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01450878
Recruitment Status : Terminated (Lack of patients eligible for the study.)
First Posted : October 12, 2011
Last Update Posted : September 5, 2016
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Limoges

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.


Condition or disease Intervention/treatment Phase
Ischemia Drug: beta-epoietin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interest of a High Dose of Erythropoietin Administered During Graft Processing for Early Graft Outcome in Kidney Transplant Recipients.
Study Start Date : December 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Graft with EPO
intravenous 1000 000UI beta-epoietin one hour before organe retrieval.
Drug: beta-epoietin
100 000UI beta-epoietin injection one hour before organ retrieval

No Intervention: graft without EPO
no injection befoe organ retrieval



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The incidence of delayed graft function defined as follows: [ Time Frame: 48 hours ]
    The incidence of delayed graft function defined as follows: combination of the need for dialysis (except dialysis for hyperkalemia or volume overload) or creatinine reduction ratio of less than 25% within the first 48 h post-transplant.

  2. MDRD glomerular filtration rate at one and three months [ Time Frame: three months ]
    MDRD glomerular filtration rate at one and three months

  3. The incidence of acute rejection during the first three months [ Time Frame: three months ]
    The incidence of acute rejection during the first three months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450878


Locations
Show Show 18 study locations
Sponsors and Collaborators
University Hospital, Limoges
Hoffmann-La Roche
Investigators
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Principal Investigator: Marie ESSIG, MD CHU LIMOGES
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01450878    
Other Study ID Numbers: I09002 FRETEP
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016
Keywords provided by University Hospital, Limoges:
high dose of EPO
transplant kidney
cadaveric organ donor
mono-organ (kidney) retrieval
patient
kidney graft
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes