effect of epoetin beta on renal function within 30 days following a kidney transplant

Conditions: Kidney Failure

Summary: 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

Eligibility 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)

Keywords: kidney failure kidney transplant graft function haemoglobin epoetin