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

Chronic Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00086164
• Other study ID #: CGT003-05
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: June 25, 2004
• Last updated: July 14, 2005
• Start date: May 2004

Study information

• Verified date: July 2005
• Source: Anesiva, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Renal Failure
• Hyperplasia
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• edifoligide (E2F Decoy)

Locations

Country	Name	City	State
United States	Emory University, Renal Division	Atlanta	Georgia
United States	Vascular Surgery Associates	Baton Rouge	Louisiana
United States	Montefiore Medical Center	Bronx	New York
United States	Nephrology Clinical Research Center	Charlottesville	Virginia
United States	Stoney Island Dialysis	Chicago	Illinois
United States	University Transplant	Chicago	Illinois
United States	Henry Ford Hospital	Detroit	Michigan
United States	Surgical Education	Greenville	South Carolina
United States	Outcomes Research International, Inc.	Hudson	Florida
United States	Methodist Hospital, Tower Surgical	Indianapolis	Indiana
United States	Thoracic & Cardiovascular Healthcare Foundation	Lansing	Michigan
United States	National Institute of Clinical Research, American Medical Tower	Los Angeles	California
United States	University of Miami, School of Medicine	Miami	Florida
United States	Tulane Center for Abdominal Transplant	New Orleans	Louisiana
United States	NYU Medical Center	New York	New York
United States	St. Luke's Hospital, Department of Surgery	New York	New York
United States	University of Rochester, The Center for Vascular Disease	Rochester	New York
United States	University of Utah School of Medicine, Dept of Surgery	Salt Lake City	Utah
United States	St. Louis University, Division of Nephrology	St. Louis	Missouri
United States	LifeLink Transplant Institute	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Anesiva, Inc.

Country where clinical trial is conducted

United States,