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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

January 18, 2007
May 25, 2010
February 2007
February 2010   (final data collection date for primary outcome measure)
Decrease in Delayed Graft Function
Same as current
Complete list of historical versions of study NCT00425126 on ClinicalTrials.gov Archive Site
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Effect of Procrit (Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation
Effect of Procrit(Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation

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.

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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Delayed Graft Function
Drug: Epoetin Alfa
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Sureshkumar KK, Hussain SM, Ko TY, Thai NL, Marcus RJ. Effect of high-dose erythropoietin on graft function after kidney transplantation: a randomized, double-blind clinical trial. Clin J Am Soc Nephrol. 2012 Sep;7(9):1498-506. doi: 10.2215/CJN.01360212. Epub 2012 Jun 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00425126
RC-4044
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West Penn Allegheny Health System
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Principal Investigator: Richard J Marcus, MD West Penn Allegheny Health System
West Penn Allegheny Health System
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP