PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
Phase 4
Completed
- Conditions
- Patients Receiving a Kidney From a Non-Heart-Beating Donor
- Interventions
- Registration Number
- NCT00157300
- Lead Sponsor
- Leiden University Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
- Adult patients
- Receiving a kidney from a non-heart-beating donor category 3
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epoetin beta Epoetin beta -
- Primary Outcome Measures
Name Time Method incidence of delayed graft function and primary non function after kidney transplantation within12 weeks after transplantation
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Other transplantation centers
🇳🇱To Be Determined, Netherlands