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Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant (Neo-PDGF)

This study has been completed.
Roche Pharma AG
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens Identifier:
First received: December 30, 2008
Last updated: April 27, 2016
Last verified: April 2016
Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.

Condition Intervention Phase
Kidney Failure
Drug: epoetin beta (NeoRecormon ®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

Resource links provided by NLM:

Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • The evolution of renal function [ Time Frame: 90 days ]
  • The survival of patients and grafts [ Time Frame: 90 days ]
  • The time of onset and incidence of acute rejection proved by biopsy [ Time Frame: 90 days ]
  • The correction of anemia [ Time Frame: 90 days ]
  • The need for transfusions [ Time Frame: 90 days ]
  • The need for EPO [ Time Frame: 90 days ]
  • Quality of Life [ Time Frame: 90 days ]

Enrollment: 108
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Patient will receive Epoetin Beta
Drug: epoetin beta (NeoRecormon ®)

comparison of administration of high dosage of epoetin vs no administration of epoetin

30000 UI: 4 injections

Other Name: Neorecormon
No Intervention: B

Detailed Description:

French study, prospective, multicenter, open, randomized into two parallel groups:

Group A: NeoRecormon ® 30000 UI: 4 injections Group B: control group without administration of the medical product

Period of recruitment: 18 months Duration of participation of each patient: 90 days Total duration of the test: 21 months.

Main objective : Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant.

Secondary objectives:

Comparing the 2 groups at all times J0 to J90:

  • The evolution of renal function
  • The survival of patients and grafts
  • The time of onset and incidence of acute rejection proved by biopsy
  • The correction of anemia
  • The need for transfusions
  • The need for EPO
  • Quality of Life
  • The safety processing

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males anf Females aged between 18 and 75
  • Patients having given their written consent
  • Patient determined to participate in the test and to respect the requirements
  • Patient covered by a social insurance
  • Patient to be kidney transplanted (from a cadaveric donor)
  • Patient benefiting from the 1st or 2nd kidney transplant
  • Patient formerly treated by peritoneal dialysis or hemodialysis
  • Patient receiving a graft with risk of delayed graft function (score> 7 combining age of the donor, ischemia time, receiver ethnicity and cause of death)
  • Patient to receive treatment with basiliximab, mycophenolate mofetil, tacrolimus and corticosteroid

Exclusion Criteria:

  • Patient Pregnant or nursing
  • Patient with a disability that does not ensure the good understanding of the study and its imperatives , or patient having dependency (alcohol, drugs)
  • Patient receiving doses of epoetin beta or alpha> 30,000 IU / week or darbepoetin> 150 microg / week before transplanting
  • Patient who has participated in a clinical trial in the last month or currently included in another test
  • Patient in safeguarding justice, guardianship or trusteeship
  • Patient receiving a third transplant or hyper immune or who have a positive historic cross-match
  • Patient receiving a preemptive transplant
  • graft from a living donor
  • graft with 3 or more arteries
  • Multi-Organ Transplantation
  • Patient with heart failure stage> III
  • Patients with unstable ischemic heart disease, or have had a major coronary event less than 6 months, stroke or TIA <6 months or symptomatic arteritis of lower limbs stage ≥ 3
  • Patients with active viral infection: hepatitis B, C (PCR + only) or HIV
  • Patient with a history of anemia from erythroblastopenia
  • Patient receiving anticoagulant treatment(AVK) before renal transplantation and to be continued after transplant
  • Patient with a preoperative rate Hb> 14 g / dL (before ultrafiltration)
  • A patient with known hypersensitivity to the active substance or to any of the excipients, or to benzoic acid
  • Patients with poorly controlled hypertension in the weeks before transplantation (Diastolic Blood Pressure ≥ 110 mm Hg with more than 3 antihypertensive drugs)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00815867

Amiens hospital
Amiens, France, 80000
Brest, France, 29200
MONDOR Hospital
Creteil, France, 94010
Grenoble, France, 38000
Kremlin Bicêtre Hospital
Le Kremlin Bicêtre, France, 94275
Lille, France, 59 000
CHU Nantes, Hotel-Dieu Hospital
Nantes, France, 44093
CHU Nice, Pasteur Hospital
Nice, France, 06000
Georges Pompidou European Hospital
Paris, France, 75015
TENON Hospital
Paris, France, 75020
Necker Hospital
Paris, France, 75
Poitiers, France, 86000
Reims, France, 51100
Bois Guillaume Hospital
Rouen, France, 76230
FOCH Hospital
Suresnes, France, 92151
Toulouse, France, 31000
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Roche Pharma AG
Principal Investigator: CHOUKROUN Gabriel, Ph D CHU Amiens
Principal Investigator: MARTINEZ Franck, Ph D Necker Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire, Amiens Identifier: NCT00815867     History of Changes
Other Study ID Numbers: PI07-PR-CHOUKROUN
2007/14 CPP
2007-002562-35 EudraCT
Study First Received: December 30, 2008
Last Updated: April 27, 2016

Keywords provided by Centre Hospitalier Universitaire, Amiens:
kidney failure
kidney transplant
graft function

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics processed this record on May 25, 2017