End Stage Renal DiseasePhase 3AdV-VANTAGENCT00895479
Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence
A Phase 3 study testing Graft placement surgery plus Trinam therapy in people with End Stage Renal Disease, run by Ark Therapeutics Ltd at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Graft placement surgery plus Trinam therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 12 sitesUnited States
- Study dates
- Apr 2009to Sep 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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®.
Who cannot join
- 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%.
Show all 17Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Baton Rouge General Hospital
Baton Rouge, Louisiana, LA 70809
University of Cincinnati
Cincinnati, Ohio, OH 45267
Ohio State University Division of Nephrology
Columbus, Ohio, OH 43210
Duke University Medical Center
Durham, North Carolina, NC 27710
Long Beach VA Healthcare System
Long Beach, California, CA 90822
Texas Tech University Medical Center
Lubbock, Texas, TX 79415
Mount Sinai Medical Center
New York, New York, NY 10029
St Luke's Roosevelt Hospital
New York, New York, NY10025
Four Rivers Clinical Research Inc
Paducah, Kentucky, KY 42003
Harborview Medical Center
Seattle, Washington, WA 98104
Louisiana State University Health Sciences Center
Shreveport, Louisiana, LA 71103
Washington University School of Medicine
St Louis, Missouri, MO 63110
About this study
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
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.
- Conditions
- End Stage Renal Disease
- Being tested
- Graft placement surgery plus Trinam therapy
- Keywords
- End Stage Renal Disease, ESRD, Hemodialysis, Access Graft
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graft placement surgery plus Trinam therapyProcedure or surgery
Trinam arm: graft placement surgery plus 1ml perivascular administration of Trinam vector.
Control arm: graft placement surgery
| Study group | Role | What they receive |
|---|---|---|
| Trinam | Experimental | Graft placement plus Trinam therapy Receives: Procedure: Graft placement surgery plus Trinam therapy |
| Control | No intervention | Graft placement surgery alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Unassisted Patency
Measured: 18 Months
Secondary outcomes (1)
Graft Survival. Number and rate of graft interventions.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: Strategic reasons. Seeking partner for future development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ark Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895479
- Sponsor's protocol ID
- Ark 103
- Acronym
- AdV-VANTAGE
- Status last verified
- Nov 2010
- First submitted
- 7 May 2009
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00895479
- Acronym / sponsor ID
- AdV-VANTAGE / Ark 103
- Conditions
- End Stage Renal Disease
- Keywords
- End Stage Renal Disease, ESRD, Hemodialysis, Access Graft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic reasons. Seeking partner for future development.
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ark Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 8 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trinam | Experimental | Procedure: Graft placement surgery plus Trinam therapyGraft placement plus Trinam therapy |
| Control | No intervention | –Graft placement surgery alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graft placement surgery plus Trinam therapyTrinam arm: graft placement surgery plus 1ml perivascular administration of Trinam vector. Control arm: graft placement surgery | Procedure or surgery | Trinam |
Primary outcome
Primary Unassisted Patency
Time frame: 18 Months
1 secondary outcome
Graft Survival. Number and rate of graft interventions.
Time frame: 2.5 years
Results and safety
The study was stopped early (reason given: Strategic reasons. Seeking partner for future development.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Graft placement surgery plus Trinam therapy in people with End Stage Renal Disease, run by Ark Therapeutics Ltd at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic reasons. Seeking partner for future development.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Unassisted Patency (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2010.