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Effect of Procrit (Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation

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ClinicalTrials.gov Identifier: NCT00425126
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : May 27, 2010
Sponsor:
Information provided by:
West Penn Allegheny Health System

Study Description
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Brief Summary:
Delayed graft function (DGF) is a major complication following deceased donor renal transplantation. The surgical procedure of harvesting a kidney from a cadaveric donor and implanting the kidney into the recipient inevitably causes some amount of injury. While not always clinically significant, anywhere from 10-50% of transplant patients may develop DGF. Ongoing research in animal models has demonstrated benefit with administration of erythropoietin. The investigators propose to study the effect of Procrit(Epoetin Alfa) on delayed graft function in subjects undergoing kidney transplantation.

Condition or disease Intervention/treatment Phase
Delayed Graft Function Drug: Epoetin Alfa Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Procrit(Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation
Study Start Date : February 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Decrease in Delayed Graft Function

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting for kidney transplantation
  • Age > 18
  • Deceased donor kidney transplant

Exclusion Criteria:

  • History of thrombosis or hypercoagulable state
  • Receiving Coumadin or Heparin
  • Hemoglobin >=14 g/dl
  • Uncontrolled hypertension
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425126


Locations
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
West Penn Allegheny Health System
Investigators
Principal Investigator: Richard J Marcus, MD West Penn Allegheny Health System
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00425126     History of Changes
Other Study ID Numbers: RC-4044
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: May 2010

Keywords provided by West Penn Allegheny Health System:
Delayed Graft Function
Kidney Transplantation

Additional relevant MeSH terms:
Delayed Graft Function
Pathologic Processes
Epoetin Alfa
Hematinics