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

This study has been completed.
Sponsor:
Information provided by:
West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00425126
First received: January 18, 2007
Last updated: May 25, 2010
Last verified: May 2010
History of Changes
  Purpose
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 Intervention Phase
Delayed Graft Function Drug: Epoetin Alfa Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Procrit(Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by West Penn Allegheny Health System:

Primary Outcome Measures:
  • Decrease in Delayed Graft Function
Enrollment: 76
Study Start Date: February 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Study First Received: January 18, 2007
Last Updated: May 25, 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

ClinicalTrials.gov processed this record on July 24, 2017