NCT00157300

PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients Receiving a Kidney From a Non-Heart-Beating Donor

Interventions

Type	Name	Description
DRUG	Epoetin beta	intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.

Timeline

• Start date: 2005-07-01
• Primary completion: 2010-03-01
• Completion: 2010-07-01
• First posted: 2005-09-12
• Last updated: 2010-08-02

Locations

2 sites across 1 country: Netherlands