NCT01450878

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

18 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

October 10, 2011

Last Update Submit

September 2, 2016

Conditions

Ischemia

Keywords

high dose of EPOtransplant kidneycadaveric organ donormono-organ (kidney) retrievalpatientkidney graft

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • The incidence of delayed graft function defined as follows:

    48 hours

  • MDRD glomerular filtration rate at one and three months

    three months

  • The incidence of acute rejection during the first three months

    three months

Study Arms (2)

Graft with EPO

EXPERIMENTAL

intravenous 1000 000UI beta-epoietin one hour before organe retrieval.

Drug: beta-epoietin

graft without EPO

NO INTERVENTION

no injection befoe organ retrieval

Interventions

beta-epoietinDRUG

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

Graft with EPO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • living donors,
  • age under 18 years,
  • multi-organ retrieval,
  • donor hematocrit above 45%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Néphrologie

Angers, 49000, France

Location

CHU d'ANGERS - CHPOT

Angers, 49933, France

Location

CHU de BORDEAUX - CHPOT

Bordeaux, 33076, France

Location

CHU de BORDEAUX - Service de Néphrologie

Bordeaux, 33076, France

Location

Néphrologie

Brest, 29 609, France

Location

CHU de BREST - CHPOT

Brest, 29609, France

Location

CHU de LIMOGES - CHPOT

Limoges, 87042, France

Location

CHU de LIMOGES - Service de Néphrologie

Limoges, 87042, France

Location

CHU de NANTES - CHPOT

Nantes, 44093, France

Location

CHU de NANTES - Service de Néphrologie

Nantes, 44093, France

Location

Néphrologie

Poitiers, 86000, France

Location

CHU de POITIERS - CHPOT

Poitiers, 86021, France

Location

CHU de RENNES - CHPOT

Rennes, 35033, France

Location

CHU de RENNES - Service de Néphrologie

Rennes, 35033, France

Location

CHU de TOULOUSE - CHPOT

Toulouse, 31059, France

Location

CHU de TOULOUSE - Service de Néphrologie

Toulouse, 31059, France

Location

Néphrologie

Tours, 37000, France

Location

CHU de TOURS - CHPOT

Tours, 37044, France

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marie ESSIG, MD

    CHU LIMOGES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 12, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 5, 2016

Record last verified: 2016-09

Locations

FR(18)