We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00425126
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : May 27, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Delayed Graft Function Drug: Epoetin Alfa Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
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
Study Start Date : February 2007
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Decrease in Delayed Graft Function

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
West Penn Allegheny Health System
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):
ClinicalTrials.gov Identifier: NCT00425126     History of Changes
Other Study ID Numbers: RC-4044
First Posted: January 22, 2007    Key Record Dates
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