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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborator: Roche Pharma AG
• Treatments: Epoetin Alfa

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)