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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Trinam arm: graft placement surgery plus 1ml perivascular administration of Trinam vector. Control arm: graft placement surgery
Long Beach VA Healthcare System
Long Beach, California, United States
Four Rivers Clinical Research Inc
Paducah, Kentucky, United States
Baton Rouge General Hospital
Baton Rouge, Louisiana, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mount Sinai Medical Center
New York, New York, United States
St Luke's Roosevelt Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohio State University Division of Nephrology
Columbus, Ohio, United States
...and 2 more locations
Primary Unassisted Patency
Time frame: 18 Months
Graft Survival. Number and rate of graft interventions.
Time frame: 2.5 years
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