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

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. Identifier: NCT00086164
Recruitment Status : Terminated
First Posted : June 29, 2004
Last Update Posted : July 19, 2005
Information provided by:
Anesiva, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperplasia Chronic Renal Failure Drug: edifoligide (E2F Decoy) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : May 2004

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00086164

United States, California
National Institute of Clinical Research, American Medical Tower
Los Angeles, California, United States, 90017
United States, Florida
Outcomes Research International, Inc.
Hudson, Florida, United States, 34667
University of Miami, School of Medicine
Miami, Florida, United States, 33136
Tampa General Hospital
Tampa, Florida, United States, 33600
LifeLink Transplant Institute
Tampa, Florida, United States, 33606
United States, Georgia
Emory University, Renal Division
Atlanta, Georgia, United States, 30322
United States, Illinois
University Transplant
Chicago, Illinois, United States, 60612
Stoney Island Dialysis
Chicago, Illinois, United States, 60617
United States, Indiana
Methodist Hospital, Tower Surgical
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Vascular Surgery Associates
Baton Rouge, Louisiana, United States, 70808
Tulane Center for Abdominal Transplant
New Orleans, Louisiana, United States, 70112
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States, 48910
United States, Missouri
St. Louis University, Division of Nephrology
St. Louis, Missouri, United States, 63110
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
NYU Medical Center
New York, New York, United States, 10016
St. Luke's Hospital, Department of Surgery
New York, New York, United States, 10025
University of Rochester, The Center for Vascular Disease
Rochester, New York, United States, 14642
United States, South Carolina
Surgical Education
Greenville, South Carolina, United States, 29605
United States, Utah
University of Utah School of Medicine, Dept of Surgery
Salt Lake City, Utah, United States, 84132
United States, Virginia
Nephrology Clinical Research Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Anesiva, Inc. Identifier: NCT00086164     History of Changes
Other Study ID Numbers: CGT003-05
First Posted: June 29, 2004    Key Record Dates
Last Update Posted: July 19, 2005
Last Verified: July 2005

Keywords provided by Anesiva, Inc.:
E2F Decoy
Chronic Renal failure
AV Graft
neointimal hyperplasia

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Pathologic Processes
Kidney Diseases
Urologic Diseases