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

This study has been terminated.
(Lack of patients eligible for the study.)
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01450878
First received: October 10, 2011
Last updated: April 16, 2013
Last verified: December 2011
  Purpose

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 Intervention Phase
Ischemia
Drug: beta-epoietin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • a plasma creatinin level [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    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:
  • The incidence of delayed graft function defined as follows: [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    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.

  • MDRD glomerular filtration rate at one and three months [ Time Frame: three months ] [ Designated as safety issue: Yes ]
    MDRD glomerular filtration rate at one and three months

  • The incidence of acute rejection during the first three months [ Time Frame: three months ] [ Designated as safety issue: Yes ]
    The incidence of acute rejection during the first three months


Enrollment: 6
Study Start Date: December 2011
Estimated Study Completion Date: November 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450878

Locations
France
Néphrologie
Angers, France, 49000
CHU d'ANGERS - CHPOT
Angers, France, 49933
CHU de BORDEAUX - CHPOT
Bordeaux, France, 33076
CHU de BORDEAUX - Service de Néphrologie
Bordeaux, France, 33076
Néphrologie
Brest, France, 29 609
CHU de BREST - CHPOT
Brest, France, 29609
CHU de LIMOGES - CHPOT
Limoges, France, 87042
CHU de LIMOGES - Service de Néphrologie
Limoges, France, 87042
CHU de NANTES - CHPOT
Nantes, France, 44093
CHU de NANTES - Service de Néphrologie
Nantes, France, 44093
Néphrologie
Poitiers, France, 86000
CHU de POITIERS - CHPOT
Poitiers, France, 86021
CHU de RENNES - CHPOT
Rennes, France, 35033
CHU de RENNES - Service de Néphrologie
Rennes, France, 35033
CHU de TOULOUSE - Service de Néphrologie
Toulouse, France, 31059
CHU de TOULOUSE - CHPOT
Toulouse, France, 31059
CHU de TOURS - CHPOT
Tours, France, 37044
Néphrologie
Tours, France, 37000
Sponsors and Collaborators
University Hospital, Limoges
Hoffmann-La Roche
Investigators
Principal Investigator: Marie ESSIG, MD CHU LIMOGES
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01450878     History of Changes
Other Study ID Numbers: I09002 FRETEP
Study First Received: October 10, 2011
Last Updated: April 16, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014