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

This study is currently recruiting participants.

Verified by West Penn Allegheny Health System, January 2009

First Received: January 18, 2007 Last Updated: January 29, 2009 History of Changes

Sponsor:	West Penn Allegheny Health System
Information provided by:	West Penn Allegheny Health System
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. 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 IV

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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Erythropoietin 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

Estimated Enrollment:	76
Study Start Date:	February 2007
Estimated Study Completion Date:	December 2009

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

West Penn Allegheny Health System

Investigators

Principal Investigator:

Richard J Marcus, MD

West Penn Allegheny Health System

More Information

No publications provided

Study ID Numbers:	RC-4044
Study First Received:	January 18, 2007
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00425126 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by West Penn Allegheny Health System:

Delayed Graft Function
Kidney Transplantation

Additional relevant MeSH terms:

Epoetin Alfa
Pathologic Processes
Hematinics
Therapeutic Uses

Hematologic Agents
Delayed Graft Function
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009