NCT00425126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

May 27, 2010

Status Verified

May 1, 2010

Enrollment Period

3 years

First QC Date

January 18, 2007

Last Update Submit

May 25, 2010

Conditions

Delayed Graft Function

Keywords

Delayed Graft FunctionKidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Decrease in Delayed Graft Function

Interventions

Epoetin AlfaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting for kidney transplantation
  • Age \> 18
  • Deceased donor kidney transplant

You may not qualify if:

  • History of thrombosis or hypercoagulable state
  • Receiving Coumadin or Heparin
  • Hemoglobin \>=14 g/dl
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (1)

  • 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.

    PMID: 22745272DERIVED

MeSH Terms

Conditions

Delayed Graft Function

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Richard J Marcus, MD

    West Penn Allegheny Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2007

First Posted

January 22, 2007

Study Start

February 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

May 27, 2010

Record last verified: 2010-05

Locations

US(1)