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:

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


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):

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
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 May 25, 2017

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