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

This study is currently recruiting participants.
Verified by Allegheny General Hospital, May 2008

Sponsored by: Allegheny General Hospital
Information provided by: Allegheny General Hospital
ClinicalTrials.gov Identifier: NCT00425126
  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. We 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 IV

MedlinePlus related topics:   Kidney Transplantation   

ChemIDplus related topics:   Epoetin alfa    Erythropoietin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title:   Effect of Procrit(Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation

Further study details as provided by Allegheny General Hospital:

Primary Outcome Measures:
  • Decrease in Delayed Graft Function

Estimated Enrollment:   76
Study Start Date:   February 2007
Estimated Study Completion Date:   December 2008

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425126

Contacts
Contact: Richard Marcus, MD     412-359-3319     rmarcus@wpahs.org    

Locations
United States, Pennsylvania
Allegheny General Hospital     Recruiting
      Pittsburgh, Pennsylvania, United States, 15212

Sponsors and Collaborators
Allegheny General Hospital

Investigators
Principal Investigator:     Richard J Marcus, MD     Allegheny General Hospital    
  More Information


Study ID Numbers:   RC-4044
First Received:   January 18, 2007
Last Updated:   May 6, 2008
ClinicalTrials.gov Identifier:   NCT00425126
Health Authority:   United States: Institutional Review Board

Keywords provided by Allegheny General Hospital:
Delayed Graft Function  
Kidney Transplantation  

Study placed in the following topic categories:
Epoetin Alfa
Death
Delayed Graft Function

Additional relevant MeSH terms:
Pathologic Processes
Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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