Suspended

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

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What is being tested

edifoligide (E2F Decoy)

Drug
Who is being recruted

Hyperplasia

+ Chronic Renal Failure
From 18 to 79 Years
+20 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Phase 1
Interventional
Study Start: May 2004

See protocol details

Summary

Principal SponsorAnesiva, Inc.
Last updated: July 19, 2005
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual 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 
Principal SponsorAnesiva, Inc.
Last updated: July 19, 2005
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.
Design Details
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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 79 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hyperplasia
Chronic Renal Failure
Criteria
7 inclusion criteria required to participate
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

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13 exclusion criteria prevent from participating
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)

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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 TowerLos Angeles, United StatesSee the location
Suspended
Outcomes Research International, Inc.Hudson, United States
Suspended
University of Miami, School of MedicineMiami, United States
Suspended
Tampa General HospitalTampa, United States
Suspended21 Study Centers