PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
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|ClinicalTrials.gov Identifier: NCT00157300|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 2, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients Receiving a Kidney From a Non-Heart-Beating Donor||Drug: Epoetin beta||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||July 2010|
|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
- incidence of delayed graft function and primary non function after kidney transplantation [ Time Frame: within12 weeks after transplantation ]
- duration of dialysis treatment [ Time Frame: within 12 weeks after transplantation ]
- incidence of acute rejection episodes [ Time Frame: till one year after transplantation ]
- renal function at 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months after transplantation ]
- patient and graft survival [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157300
|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|