Prevention of Vascular Access Graft Failure in Patients With Chronic Renal Failure Requiring Hemodialysis
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
1 other identifier
interventional
N/A
1 country
21
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.
Trial Health
Trial Health Score
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21 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 25, 2004
CompletedFirst Posted
Study publicly available on registry
June 29, 2004
CompletedJuly 19, 2005
July 1, 2005
June 25, 2004
July 14, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anesiva, Inc.lead
Study Sites (21)
National Institute of Clinical Research, American Medical Tower
Los Angeles, California, 90017, United States
Outcomes Research International, Inc.
Hudson, Florida, 34667, United States
University of Miami, School of Medicine
Miami, Florida, 33136, United States
Tampa General Hospital
Tampa, Florida, 33600, United States
LifeLink Transplant Institute
Tampa, Florida, 33606, United States
Emory University, Renal Division
Atlanta, Georgia, 30322, United States
University Transplant
Chicago, Illinois, 60612, United States
Stoney Island Dialysis
Chicago, Illinois, 60617, United States
Methodist Hospital, Tower Surgical
Indianapolis, Indiana, 46202, United States
Vascular Surgery Associates
Baton Rouge, Louisiana, 70808, United States
Tulane Center for Abdominal Transplant
New Orleans, Louisiana, 70112, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910, United States
St. Louis University, Division of Nephrology
St Louis, Missouri, 63110, United States
NYU Medical Center
New York, New York, 10016, United States
St. Luke's Hospital, Department of Surgery
New York, New York, 10025, United States
University of Rochester, The Center for Vascular Disease
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Surgical Education
Greenville, South Carolina, 29605, United States
University of Utah School of Medicine, Dept of Surgery
Salt Lake City, Utah, 84132, United States
Nephrology Clinical Research Center
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2004
First Posted
June 29, 2004
Study Start
May 1, 2004
Last Updated
July 19, 2005
Record last verified: 2005-07