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

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

Detailed Description
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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

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

Conditions
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Kidney Failure

Intervention / Treatment
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* Drug: epoetin beta (NeoRecormon ®)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Patient will receive Epoetin Beta | Drug: epoetin beta (NeoRecormon ®)<br>* comparison of administration of high dosage of epoetin vs no administration of epoetin 30000 UI: 4 injections<br>* Other names: Neorecormon;|
| No Intervention: B<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evolution of renal function |  | 90 days | 
| The survival of patients and grafts |  | 90 days | 
| The time of onset and incidence of acute rejection proved by biopsy |  | 90 days | 
| The correction of anemia |  | 90 days | 
| The need for transfusions |  | 90 days | 
| The need for EPO |  | 90 days | 
| Quality of Life |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney failure, kidney transplant, graft function, haemoglobin, epoetin