Prevention of Vascular Access Graft Failure in Patients With Chronic Renal Failure Requiring Hemodialysis

July 14, 2005 updated by: Anesiva, Inc.

A Phase 1/2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Pilot Trial to Assess the Effect of Treatment of the Recipient Vein of a Polytetrafluoroethylene (PTFE) Vascular Access Graft With Two Concentrations of E2F Decoy as Compared to Placebo on Neointimal Hyperplasia and the Preservation of Graft Function in Patients With Chronic Renal Failure Requiring Hemodialysis

The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months after enrollment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90017
        • National Institute of Clinical Research, American Medical Tower
    • Florida
      • Hudson, Florida, United States, 34667
        • Outcomes Research International, Inc.
      • Miami, Florida, United States, 33136
        • University of Miami, School of Medicine
      • Tampa, Florida, United States, 33600
        • Tampa General Hospital
      • Tampa, Florida, United States, 33606
        • LifeLink Transplant Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University, Renal Division
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University Transplant
      • Chicago, Illinois, United States, 60617
        • Stoney Island Dialysis
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hospital, Tower Surgical
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Vascular Surgery Associates
      • New Orleans, Louisiana, United States, 70112
        • Tulane Center For Abdominal Transplant
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Lansing, Michigan, United States, 48910
        • Thoracic & Cardiovascular Healthcare Foundation
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • St. Louis University, Division of Nephrology
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10016
        • NYU Medical Center
      • New York, New York, United States, 10025
        • St. Luke's Hospital, Department of Surgery
      • Rochester, New York, United States, 14642
        • University of Rochester, The Center for Vascular Disease
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Surgical Education
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah School of Medicine, Dept of Surgery
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Nephrology Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be scheduled to undergo placement of a new straight or loop arm PTFE arteriovenous hemodialysis access graft or a Vectragraft® (Thoratec, Inc.)
  • Be currently receiving chronic dialysis or be expected to begin hemodialysis within 4 weeks of placement of the index PTFE graft
  • Have undergone an assessment of patency (such as venography) of central veins if any of the following conditions have occurred on the ipsilateral arm intended for graft placement: presence of collateral veins, upper extremity edema or increased size (relative to the contralateral arm), history of subclavian catheter, transvenous pacemaker, or history of trauma or surgery that may have involved the neck or chest veins
  • Be > 18 and <80 years old
  • Have a documented negative serum pregnancy test (for all women of childbearing potential)
  • Be using an acceptable method of birth control if of reproductive potential and agree to continue using the birth control for at least 3 months following the graft procedure
  • Have agreed to participate voluntarily and have signed and dated an IRB/EC approved, Patient Informed Consent form

Exclusion Criteria:

  • Have an intended recipient vein >6 mm or <3 mm in diameter
  • Have a history of three or more previous PTFE grafts
  • Have uncorrected central vein (including the subclavian vein) stenosis
  • Have markedly diminished arterial pulses in the access location (unless adequate flow has been documented by arteriography or Doppler ultrasound)
  • Anticipate receipt of a renal transplant within 6 months of enrollment into this study
  • Have anticipated use of the index PTFE graft <14 days after enrollment (this does not apply to Vectragraft®)
  • Have a known allergy to iodinated contrast
  • Have a known hypercoagulable state (e.g., antithrombin III deficiency; antiphospholipid or anticardiolipin antibodies; Factor V Leiden; circulating lupus anticoagulant; current, active, heparin-induced thrombocytopenia; Protein C or S deficiency; or a history of recurrent deep venous thrombosis not related to AV access)
  • Have been in another investigational (i.e., nonapproved) drug or device study within the previous 30 days or prior participation in another clinical study with E2F Decoy
  • Have been previously enrolled in this study for an earlier access graft
  • Have any comorbid, nonrenal condition that makes 6-month survival questionable (e.g., end-stage cancer, advanced heart failure)
  • Have a known or suspected history of drug or alcohol abuse within the previous 6 months
  • Have a known allergy to any component of the investigational product (drug or device), including latex

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anesiva, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Registration Dates

First Submitted

June 25, 2004

First Submitted That Met QC Criteria

June 28, 2004

First Posted (Estimate)

June 29, 2004

Study Record Updates

Last Update Posted (Estimate)

July 19, 2005

Last Update Submitted That Met QC Criteria

July 14, 2005

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGT003-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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