NCT00157300
Completed
Phase 4
PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
Leiden University Medical Center2 sites in 1 country92 target enrollmentJuly 2005
InterventionsEpoetin beta
DrugsEpoetin beta
Overview
- Phase
- Phase 4
- Intervention
- Epoetin beta
- Conditions
- Patients Receiving a Kidney From a Non-Heart-Beating Donor
- Sponsor
- Leiden University Medical Center
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- incidence of delayed graft function and primary non function after kidney transplantation
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Epoetin beta
Intervention: Epoetin beta
Outcomes
Primary Outcomes
incidence of delayed graft function and primary non function after kidney transplantation
Time Frame: within12 weeks after transplantation
Secondary Outcomes
- 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)
- duration of dialysis treatment(within 12 weeks after transplantation)
Study Sites (2)
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