search
Back to results

Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence (AdV-VANTAGE)

Primary Purpose

End Stage Renal Disease

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Graft placement surgery plus Trinam therapy
Sponsored by
Ark Therapeutics Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring End Stage Renal Disease, ESRD, Hemodialysis, Access Graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with end stage renal disease undergoing either initial placement or replacement (after failure of previous vascular access) of an end-to-side or end-to-end 6.0 mm synthetic PTFE arteriovenous hemodialysis access arm graft.
  • Male or female aged 18 years or over.
  • Patients who signed the informed consent form.
  • Patients who are expected to undergo dialysis at nominated facilities for the duration of the study.
  • Patients who have agreed to participate in the additional four year gene therapy safety monitoring.
  • Patients who are willing to agree they will not have a kidney transplant for four weeks post treatment with Trinam®.
  • Patients who have undergone arterial and venous mapping to ensure an adequate and appropriate access site is available for placement of either an end-to-side or an end-to-end 6.0 mm synthetic PTFE arteriovenous hemodialysis access arm graft with or without the addition of Trinam®.

Exclusion Criteria:

  • Patients who are unable to understand and sign the consent form.
  • Patients undergoing surgical revision of an existing graft.
  • Exclude patients from the study if they have moderate or severe macular edema moderate or severe proliferative diabetic retinopathy
  • Current diagnosis of cancer with exception of non-melanoma skin cancers.
  • Hepatic dysfunction defined as AST and / or ALT > 2 times the Upper Limit of Normal.
  • Diabetic patients with Hemoglobin A1C value of >10%.
  • White blood cell (WBC) count < 2.0 x 109/L.
  • Prior anticoagulant therapy within 14 days prior to surgery is an exclusion.
  • Known sensitivity to collagen.
  • Pregnancy, lactation or lack of effective contraception both in women and in men of childbearing potential.
  • Previous participation in any Trinam® study.
  • Receipt of any investigational drug within 30 days prior to study enrollment or participation in any concurrently running trial involving investigational intervention.
  • Any medical or psychiatric condition that compromises the ability to participate in the study.
  • Known or suspected drug or alcohol abuse in the past six months.
  • Life expectancy of less than one year.
  • Known immunodeficiency disease.
  • Known chronic hepatitis of viral or non-viral etiology and / or a history of decompensated liver failure of any etiology.

Sites / Locations

  • Long Beach VA Healthcare System
  • Four Rivers Clinical Research Inc
  • Baton Rouge General Hospital
  • Louisiana State University Health Sciences Center
  • Washington University School of Medicine
  • Mount Sinai Medical Center
  • St Luke's Roosevelt Hospital
  • Duke University Medical Center
  • University of Cincinnati
  • Ohio State University Division of Nephrology
  • Texas Tech University Medical Center
  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Trinam

Control

Arm Description

Graft placement plus Trinam therapy

Graft placement surgery alone

Outcomes

Primary Outcome Measures

Primary Unassisted Patency

Secondary Outcome Measures

Graft Survival. Number and rate of graft interventions.

Full Information

First Posted
May 7, 2009
Last Updated
November 18, 2010
Sponsor
Ark Therapeutics Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT00895479
Brief Title
Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence
Acronym
AdV-VANTAGE
Official Title
A Phase III, Randomized, Controlled, Open Label, Multicenter Study of the Efficacy and Safety of Trinam® (EG004); an Assessment of Primary Unassisted Patency and Survival of Vascular Access Grafts in Hemodialysis Patients With End Stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
Strategic reasons. Seeking partner for future development.
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ark Therapeutics Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients in renal failure on hemodialysis depend on adequate and sustained vascular access. This can be achieved by surgical placement of a synthetic polytetrafluoroethylene (PTFE) graft. These patients frequently experience graft complications arising from the development of smooth muscle cell (SMC) neointimal hyperplasia in the proximity of the graft-vein anastomosis. Such complications eventually lead to stenosis, access thrombosis and graft failure. Trinam® is being developed to prolong graft survival. It is a combination product consisting of a replication deficient Adenovirus containing the human Vascular Endothelial Growth Factor D (Ad-VEGF-D) gene and a biodegradable local delivery device (collar) made of collagen. At the end of the surgical procedure to insert the PTFE graft the collagen collar is applied around the anastomosis and sealed with a collagen surgical sealant. This procedure creates a reservoir between the site of anastomosis and the collagen collar. The adenoviral vector is then injected into this reservoir, localizing the expression of the transgene to the site of the anastomosis. Expression of VEGF-D has been shown to have a vascular protective role and inhibit SMC neointimal proliferation, therefore expression of VEGF-D should prolong graft survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
End Stage Renal Disease, ESRD, Hemodialysis, Access Graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trinam
Arm Type
Experimental
Arm Description
Graft placement plus Trinam therapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
Graft placement surgery alone
Intervention Type
Procedure
Intervention Name(s)
Graft placement surgery plus Trinam therapy
Intervention Description
Trinam arm: graft placement surgery plus 1ml perivascular administration of Trinam vector. Control arm: graft placement surgery
Primary Outcome Measure Information:
Title
Primary Unassisted Patency
Time Frame
18 Months
Secondary Outcome Measure Information:
Title
Graft Survival. Number and rate of graft interventions.
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with end stage renal disease undergoing either initial placement or replacement (after failure of previous vascular access) of an end-to-side or end-to-end 6.0 mm synthetic PTFE arteriovenous hemodialysis access arm graft. Male or female aged 18 years or over. Patients who signed the informed consent form. Patients who are expected to undergo dialysis at nominated facilities for the duration of the study. Patients who have agreed to participate in the additional four year gene therapy safety monitoring. Patients who are willing to agree they will not have a kidney transplant for four weeks post treatment with Trinam®. Patients who have undergone arterial and venous mapping to ensure an adequate and appropriate access site is available for placement of either an end-to-side or an end-to-end 6.0 mm synthetic PTFE arteriovenous hemodialysis access arm graft with or without the addition of Trinam®. Exclusion Criteria: Patients who are unable to understand and sign the consent form. Patients undergoing surgical revision of an existing graft. Exclude patients from the study if they have moderate or severe macular edema moderate or severe proliferative diabetic retinopathy Current diagnosis of cancer with exception of non-melanoma skin cancers. Hepatic dysfunction defined as AST and / or ALT > 2 times the Upper Limit of Normal. Diabetic patients with Hemoglobin A1C value of >10%. White blood cell (WBC) count < 2.0 x 109/L. Prior anticoagulant therapy within 14 days prior to surgery is an exclusion. Known sensitivity to collagen. Pregnancy, lactation or lack of effective contraception both in women and in men of childbearing potential. Previous participation in any Trinam® study. Receipt of any investigational drug within 30 days prior to study enrollment or participation in any concurrently running trial involving investigational intervention. Any medical or psychiatric condition that compromises the ability to participate in the study. Known or suspected drug or alcohol abuse in the past six months. Life expectancy of less than one year. Known immunodeficiency disease. Known chronic hepatitis of viral or non-viral etiology and / or a history of decompensated liver failure of any etiology.
Facility Information:
Facility Name
Long Beach VA Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
CA 90822
Country
United States
Facility Name
Four Rivers Clinical Research Inc
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
KY 42003
Country
United States
Facility Name
Baton Rouge General Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
LA 70809
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
LA 71103
Country
United States
Facility Name
Washington University School of Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
MO 63110
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
NY 10029
Country
United States
Facility Name
St Luke's Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
NY10025
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
NC 27710
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
OH 45267
Country
United States
Facility Name
Ohio State University Division of Nephrology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
OH 43210
Country
United States
Facility Name
Texas Tech University Medical Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
TX 79415
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
WA 98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence

We'll reach out to this number within 24 hrs