Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

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

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

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)