Prevention of Vascular Access Graft Failure in Patients With Chronic Renal Failure Requiring Hemodialysis
- Conditions
- Chronic Renal FailureHyperplasia
- Registration Number
- NCT00086164
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Thoracic & Cardiovascular Healthcare Foundation
🇺🇸Lansing, Michigan, United States
St. Luke's Hospital, Department of Surgery
🇺🇸New York, New York, United States
Outcomes Research International, Inc.
🇺🇸Hudson, Florida, United States
University of Rochester, The Center for Vascular Disease
🇺🇸Rochester, New York, United States
Surgical Education
🇺🇸Greenville, South Carolina, United States
Nephrology Clinical Research Center
🇺🇸Charlottesville, Virginia, United States
National Institute of Clinical Research, American Medical Tower
🇺🇸Los Angeles, California, United States
University Transplant
🇺🇸Chicago, Illinois, United States
Emory University, Renal Division
🇺🇸Atlanta, Georgia, United States
Methodist Hospital, Tower Surgical
🇺🇸Indianapolis, Indiana, United States
University of Miami, School of Medicine
🇺🇸Miami, Florida, United States
Stoney Island Dialysis
🇺🇸Chicago, Illinois, United States
St. Louis University, Division of Nephrology
🇺🇸St. Louis, Missouri, United States
NYU Medical Center
🇺🇸New York, New York, United States
Vascular Surgery Associates
🇺🇸Baton Rouge, Louisiana, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
LifeLink Transplant Institute
🇺🇸Tampa, Florida, United States
Tulane Center for Abdominal Transplant
🇺🇸New Orleans, Louisiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Utah School of Medicine, Dept of Surgery
🇺🇸Salt Lake City, Utah, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States