Renal Graft Function After Treatment With Erythropoietin (EPO)

Ischemia Clinical Trial

— FRETEP  

Official title:

Interest of a High Dose of Erythropoietin Administered During Graft Processing for Early Graft Outcome in Kidney Transplant Recipients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01450878
• Other study ID #: I09002 FRETEP
• Status: Terminated
• Phase: Phase 3
• First received: October 10, 2011
• Last updated: September 2, 2016
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2016
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia

Intervention

Drug:
• beta-epoietin
100 000UI beta-epoietin injection one hour before organ retrieval

Locations

Country	Name	City	State
France	CHU d'ANGERS - CHPOT	Angers
France	Néphrologie	Angers
France	CHU de BORDEAUX - CHPOT	Bordeaux
France	CHU de BORDEAUX - Service de Néphrologie	Bordeaux
France	CHU de BREST - CHPOT	Brest
France	Néphrologie	Brest
France	CHU de LIMOGES - CHPOT	Limoges
France	CHU de LIMOGES - Service de Néphrologie	Limoges
France	CHU de NANTES - CHPOT	Nantes
France	CHU de NANTES - Service de Néphrologie	Nantes
France	CHU de POITIERS - CHPOT	Poitiers
France	Néphrologie	Poitiers
France	CHU de RENNES - CHPOT	Rennes
France	CHU de RENNES - Service de Néphrologie	Rennes
France	CHU de TOULOUSE - CHPOT	Toulouse
France	CHU de TOULOUSE - Service de Néphrologie	Toulouse
France	CHU de TOURS - CHPOT	Tours
France	Néphrologie	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a plasma creatinin level	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.	5 days	Yes
Secondary	The incidence of delayed graft function defined as follows:	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.	48 hours	Yes
Secondary	MDRD glomerular filtration rate at one and three months	MDRD glomerular filtration rate at one and three months	three months	Yes
Secondary	The incidence of acute rejection during the first three months	The incidence of acute rejection during the first three months	three months	Yes