Status:
TERMINATED
Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence
Lead Sponsor:
Ark Therapeutics Ltd
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00895479
Start Date
April 1 2009
End Date
September 1 2011
Last Update
November 19 2010
Active Locations (12)
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1
Long Beach VA Healthcare System
Long Beach, California, United States, CA 90822
2
Four Rivers Clinical Research Inc
Paducah, Kentucky, United States, KY 42003
3
Baton Rouge General Hospital
Baton Rouge, Louisiana, United States, LA 70809
4
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, LA 71103