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

Tracking Information

First Received Date ^ICMJE

January 18, 2007

Last Updated Date

January 29, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Decrease in Delayed Graft Function

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00425126 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment

Condition ^ICMJE

Delayed Graft Function

Intervention ^ICMJE

Drug: Epoetin Alfa

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Richard Marcus, MD

412-359-3319

rmarcus@wpahs.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00425126

Responsible Party

Study ID Numbers ^ICMJE

RC-4044

Study Sponsor ^ICMJE

West Penn Allegheny Health System

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Richard J Marcus, MD

West Penn Allegheny Health System

Information Provided By

West Penn Allegheny Health System

Verification Date

January 2009

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