Patients Receiving a Kidney From a Non-Heart-Beating Donor
Conditions
Keywords
erythropoietin, kidney transplantation, delayed graft function
Brief summary
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.
Detailed description
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.
Interventions
DRUGEpoetin beta
intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.
Sponsors
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients * Receiving a kidney from a non-heart-beating donor category 3
Exclusion criteria
* Donor related factors: a prolonged warm ischaemic time (\> 45 min); a cold ischaemic time of \> 24 hours; serum creatinin of \> 150 umol/l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of delayed graft function and primary non function after kidney transplantation | within12 weeks after transplantation |
Secondary
| Measure | Time frame |
|---|---|
| duration of dialysis treatment | within 12 weeks after transplantation |
| incidence of acute rejection episodes | till one year after transplantation |
| renal function at 3, 6 and 12 months | 3, 6 and 12 months after transplantation |
| patient and graft survival | one year |
Countries
Netherlands
Outcome results
None listed