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

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT00815867
First received: December 30, 2008
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The evolution of renal function [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • The survival of patients and grafts [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • The time of onset and incidence of acute rejection proved by biopsy [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • The correction of anemia [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • The need for transfusions [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • The need for EPO [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT00815867

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

No publications provided by Centre Hospitalier Universitaire, Amiens

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov 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: October 19, 2011
Health Authority: FRANCE :Human subjects Protection Committee CPP
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014