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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:

ClinicalTrials.gov Identifier:

NCT00425126

First Posted: January 22, 2007

Last Update Posted: May 27, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

West Penn Allegheny Health System

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 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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Epoetin Alfa

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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): 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):

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.


ClinicalTrials.gov Identifier:	NCT00425126 History of Changes
Other Study ID Numbers:	RC-4044
First Submitted:	January 18, 2007
First Posted:	January 22, 2007
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

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