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

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Phase 3

Conditions: Kidney Failure

Treatments: Drug: epoetin beta (NeoRecormon ®)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00815867

PI07-PR-CHOUKROUN

2007-002562-35 EudraCT

2007/14 CPP

Details and patient eligibility

About

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

Full 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

Enrollment: 108 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

A

Experimental group

Description:

Patient will receive Epoetin Beta

Treatment:

Drug: epoetin beta (NeoRecormon ®)

B

No Intervention group