Suspended

E2F Decoy Treatment for Graft/Recipient Vein Stenosis in PTFE Vascular Access Grafts for Hemodialysis

What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+11

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 79 Years

+20 Eligibility Criteria

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 27, 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.

This is a diagnostic study focusing on patients with chronic renal failure who require hemodialysis. It aims to understand the impact of a treatment called edifoligide (E2F Decoy) on the vein that receives a polytetrafluoroethylene (PTFE) vascular access graft, a type of artificial blood vessel used in hemodialysis. The goal is to see if this treatment can reduce the narrowing of the vein and maintain the function of the graft. This research is important as it could potentially improve the longevity and effectiveness of hemodialysis treatments for patients with chronic renal failure. In this study, participants will have their vein treated with either edifoligide (E2F Decoy) or a placebo before the PTFE vascular access graft is placed. The effect of the treatment will be assessed 6 months after enrollment. The study measures the results by looking at the degree of vein narrowing and the preservation of graft function. This helps to determine if the treatment is effective in maintaining the health of the vein and the graft.

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 27, 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 ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

7 inclusion criteria required to participate

Have a documented negative serum pregnancy test (for all women of childbearing potential)

Be scheduled to undergo placement of a new straight or loop arm PTFE arteriovenous hemodialysis access graft or a Vectragraft® (Thoratec, Inc.)

Be > 18 and <80 years old

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

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13 exclusion criteria prevent from participating

Have an intended recipient vein >6 mm or <3 mm in diameter

Have been previously enrolled in this study for an earlier access graft

Have a known allergy to iodinated contrast

Have a history of three or more previous PTFE grafts

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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 StatesOpen National Institute of Clinical Research, American Medical Tower in Google Maps

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