Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence
Public ClinicalTrials.gov record NCT00895479. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00895479
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2009 (Type not available)
- Primary completion
- Sep 2011 (Estimated)
- Completion
- Sep 2011 (Estimated)
- Last update posted
- Nov 19, 2010
2009 – 2011
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Long Beach VA Healthcare System | Long Beach | California | CA 90822 | — |
| Four Rivers Clinical Research Inc | Paducah | Kentucky | KY 42003 | — |
| Baton Rouge General Hospital | Baton Rouge | Louisiana | LA 70809 | — |
| Louisiana State University Health Sciences Center | Shreveport | Louisiana | LA 71103 | — |
| Washington University School of Medicine | St Louis | Missouri | MO 63110 | — |
| Mount Sinai Medical Center | New York | New York | NY 10029 | — |
| St Luke's Roosevelt Hospital | New York | New York | NY10025 | — |
| Duke University Medical Center | Durham | North Carolina | NC 27710 | — |
| University of Cincinnati | Cincinnati | Ohio | OH 45267 | — |
| Ohio State University Division of Nephrology | Columbus | Ohio | OH 43210 | — |
| Texas Tech University Medical Center | Lubbock | Texas | TX 79415 | — |
| Harborview Medical Center | Seattle | Washington | WA 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00895479, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 19, 2010 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00895479 live on ClinicalTrials.gov.