Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+10

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 79 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 1 & 2
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorAnesiva, Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00086164
Principal SponsorAnesiva, Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 79 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsHyperplasiaKidney DiseasesKidney Failure, ChronicPathologic ProcessesUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 21 locations

Suspended

National Institute of Clinical Research, American Medical Tower

Los Angeles, United StatesSee the location
Suspended

Outcomes Research International, Inc.

Hudson, United States
Suspended

University of Miami, School of Medicine

Miami, United States
Suspended

Tampa General Hospital

Tampa, United States
Suspended21 Study Centers