Renal Graft Function After Treatment With Erythropoietin (EPO)

Phase 3

Terminated

• Conditions: Ischemia
• Interventions: Drug: beta-epoietin

• Registration Number: NCT01450878
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Study Start: 2011-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Graft with EPO	beta-epoietin	intravenous 1000 000UI beta-epoietin one hour before organe retrieval.

Primary Outcome Measures

Name	Time	Method
a plasma creatinin level	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

Name	Time	Method
The incidence of acute rejection during the first three months	three months	The incidence of acute rejection during the first three months
The incidence of delayed graft function defined as follows:	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.
MDRD glomerular filtration rate at one and three months	three months	MDRD glomerular filtration rate at one and three months

Trial Locations

Locations (15)

CHU de BREST - CHPOT; 🇫🇷 Brest, France

CHU de RENNES - CHPOT; 🇫🇷 Rennes, France

CHU de BORDEAUX - CHPOT; 🇫🇷 Bordeaux, France

CHU de TOULOUSE - Service de Néphrologie; 🇫🇷 Toulouse, France

CHU de NANTES - CHPOT; 🇫🇷 Nantes, France

CHU de NANTES - Service de Néphrologie; 🇫🇷 Nantes, France

Néphrologie; 🇫🇷 Tours, France

CHU d'ANGERS - CHPOT; 🇫🇷 Angers, France

CHU de BORDEAUX - Service de Néphrologie; 🇫🇷 Bordeaux, France

CHU de LIMOGES - CHPOT; 🇫🇷 Limoges, France

CHU de LIMOGES - Service de Néphrologie; 🇫🇷 Limoges, France

CHU de RENNES - Service de Néphrologie; 🇫🇷 Rennes, France

CHU de TOULOUSE - CHPOT; 🇫🇷 Toulouse, France

CHU de POITIERS - CHPOT; 🇫🇷 Poitiers, France

CHU de TOURS - CHPOT; 🇫🇷 Tours, France