Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation. The investigators postulate that erythropoietin reduces the risk of delayed graft function.
Randomized, double blind, placebo controlled, prospective trial in patients, receiving a kidney transplantation. Patients will be randomized to receive either Epoetin Beta (Neorecormon; Roche) or placebo. The primary endpoint will be delayed graft function. The anticipated duration of this trial is 2 year and the target sample size is 60 patients per arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
92
intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.
Leiden University Medical Center
Leiden, Netherlands
Other transplantation centers
To Be Determined, Netherlands
incidence of delayed graft function and primary non function after kidney transplantation
Time frame: within12 weeks after transplantation
duration of dialysis treatment
Time frame: within 12 weeks after transplantation
incidence of acute rejection episodes
Time frame: till one year after transplantation
renal function at 3, 6 and 12 months
Time frame: 3, 6 and 12 months after transplantation
patient and graft survival
Time frame: one year
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