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

This study has been terminated.
Sponsor:
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00086164
First received: June 25, 2004
Last updated: July 14, 2005
Last verified: July 2005
  Purpose

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 Intervention Phase
Hyperplasia
Chronic Renal Failure
Drug: edifoligide (E2F Decoy)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Anesiva, Inc.:

Study Start Date: May 2004
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086164

Locations
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.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00086164     History of Changes
Other Study ID Numbers: CGT003-05
Study First Received: June 25, 2004
Last Updated: July 14, 2005
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 18, 2014