Clinical trial NCT00815867: Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Official title: Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Failure
Keywords: kidney failure
kidney transplant
graft function
haemoglobin
epoetin
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2008-12-31
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

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)

Primary outcomes:
measure: Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant
timeFrame: 30 days
Secondary outcomes:
measure: The evolution of renal function
timeFrame: 90 days
measure: The survival of patients and grafts
timeFrame: 90 days
measure: The time of onset and incidence of acute rejection proved by biopsy
timeFrame: 90 days
measure: The correction of anemia
timeFrame: 90 days
measure: The need for transfusions
timeFrame: 90 days
measure: The need for EPO
timeFrame: 90 days
measure: Quality of Life
timeFrame: 90 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens hospital
city: Brest
country: France
facility: LA CAVALE BLANCHE Hospital
city: Creteil
country: France
facility: MONDOR Hospital
city: Grenoble
country: France
facility: MICHALLON Hospital
city: Le Kremlin Bicêtre
country: France
facility: Kremlin Bicêtre Hospital
city: Lille
country: France
facility: ALBERT CALMETTE Hospital
city: Nantes
country: France
facility: CHU Nantes, Hotel-Dieu Hospital
city: Nice
country: France
facility: CHU Nice, Pasteur Hospital
city: Paris
country: France
facility: Georges Pompidou European Hospital
city: Paris
country: France
facility: TENON Hospital
city: Paris
country: France
facility: Necker Hospital
city: Poitiers
country: France
facility: LA MILETRIE Hospital
city: Reims
country: France
facility: MAISON BLANCHE Hospital
city: Rouen
country: France
facility: Bois Guillaume Hospital
city: Suresnes
country: France
facility: FOCH Hospital
city: Toulouse
country: France
facility: RANGUEIL Hospital
city: Tours
country: France
facility: BRETONNEAU Hospital
Study officials:
affiliation: CHU Amiens
name: CHOUKROUN Gabriel, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Necker Hospital
name: MARTINEZ Franck, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez F, Kamar N, Pallet N, Lang P, Durrbach A, Lebranchu Y, Adem A, Barbier S, Cassuto-Viguier E, Glowaki F, Le Meur Y, Rostaing L, Legendre C, Hermine O, Choukroun G; NeoPDGF Study Investigators. High dose epoetin beta in the first weeks following renal transplantation and delayed graft function: Results of the Neo-PDGF Study. Am J Transplant. 2010 Jul;10(7):1695-700. doi: 10.1111/j.1600-6143.2010.03142.x.