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

Primary Purpose

Delayed Graft Function

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Epoetin Alfa
Sponsored by
West Penn Allegheny Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Graft Function focused on measuring Delayed Graft Function, Kidney Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allegheny General Hospital

Outcomes

Primary Outcome Measures

Decrease in Delayed Graft Function

Secondary Outcome Measures

Full Information

First Posted
January 18, 2007
Last Updated
May 25, 2010
Sponsor
West Penn Allegheny Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00425126
Brief Title
Effect of Procrit (Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation
Official Title
Effect of Procrit(Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
West Penn Allegheny Health System

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Graft Function
Keywords
Delayed Graft Function, Kidney Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Epoetin Alfa
Primary Outcome Measure Information:
Title
Decrease in Delayed Graft Function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Marcus, MD
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22745272
Citation
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.
Results Reference
derived

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

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