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Therapeutic Areas: Hematology
Disease Category: Hemodialysis
Trial Information
Clinical trial to test a study device for Vascular Access Grafts in Hemodialysis Patients with End Stage Renal Disease
The purpose of the study is to find out how safe Trinam® is and how well Trinam® works at making access grafts last longer. Trinam® uses a gene transfer procedure to keep the lining of the vein healthier so that it is less likely to get narrow or close off.
Study drug and study procedures will be made available to you at no cost.
To qualify, you must:
- Be at least 18 years old 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.
You will not qualify if you:
- Are pregnant or breast-feeding
- Are undergoing surgical revision of an existing graft.
- Have a current diagnosis of cancer with exception of non-melanoma skin cancers.
- Have a known sensitivity to collagen.
- Have received any experimental drug or device within 30 days prior to study enrollment
Emily Westheimer, Study Coordinator
Biomedical Research Alliance of New York
Mount Sinai Medical Center
1 Gustave L. Levy Place
New York, NY 10029
Phone: 212-241-7438
Fax: 212-987-9310
EMail: Emily.Westheimer@MountSinai.org
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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