PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
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.
Patients Receiving a Kidney From a Non-Heart-Beating Donor
Drug: Epoetin beta
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation|
- incidence of delayed graft function and primary non function after kidney transplantation [ Time Frame: within12 weeks after transplantation ] [ Designated as safety issue: No ]
- duration of dialysis treatment [ Time Frame: within 12 weeks after transplantation ] [ Designated as safety issue: No ]
- incidence of acute rejection episodes [ Time Frame: till one year after transplantation ] [ Designated as safety issue: No ]
- renal function at 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months after transplantation ] [ Designated as safety issue: No ]
- patient and graft survival [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||July 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
|Experimental: Epoetin beta||
Drug: Epoetin beta
intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.
Other Name: Neorecormon
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.
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Other transplantation centers|
|To Be Determined, Netherlands|
|Study Chair:||Ton Rabelink, MD, PhD||Leiden University Medical Center|