Status:
COMPLETED
Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Kidney Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00815867
Start Date
October 1 2007
End Date
September 1 2009
Last Update
April 28 2016
Active Locations (17)
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1
Amiens hospital
Amiens, France, 80000
2
LA CAVALE BLANCHE Hospital
Brest, France, 29200
3
MONDOR Hospital
Créteil, France, 94010
4
MICHALLON Hospital
Grenoble, France, 38000