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Sponsored by: |
Anesiva, Inc. |
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Information provided by: | Anesiva, Inc. |
ClinicalTrials.gov Identifier: | NCT00086164 |
The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months after enrollment.
Condition | Intervention | Phase |
---|---|---|
Hyperplasia Chronic Renal Failure |
Drug: edifoligide (E2F Decoy) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study |
Official Title: | A Phase 1/2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Pilot Trial to Assess the Effect of Treatment of the Recipient Vein of a Polytetrafluoroethylene (PTFE) Vascular Access Graft With Two Concentrations of E2F Decoy as Compared to Placebo on Neointimal Hyperplasia and the Preservation of Graft Function in Patients With Chronic Renal Failure Requiring Hemodialysis |
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
National Institute of Clinical Research, American Medical Tower | |
Los Angeles, California, United States, 90017 | |
United States, Florida | |
Outcomes Research International, Inc. | |
Hudson, Florida, United States, 34667 | |
Tampa General Hospital | |
Tampa, Florida, United States, 33600 | |
LifeLink Transplant Institute | |
Tampa, Florida, United States, 33606 | |
University of Miami, School of Medicine | |
Miami, Florida, United States, 33136 | |
United States, Georgia | |
Emory University, Renal Division | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
University Transplant | |
Chicago, Illinois, United States, 60612 | |
Stoney Island Dialysis | |
Chicago, Illinois, United States, 60617 | |
United States, Indiana | |
Methodist Hospital, Tower Surgical | |
Indianapolis, Indiana, United States, 46202 | |
United States, Louisiana | |
Vascular Surgery Associates | |
Baton Rouge, Louisiana, United States, 70808 | |
Tulane Center for Abdominal Transplant | |
New Orleans, Louisiana, United States, 70112 | |
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
Thoracic & Cardiovascular Healthcare Foundation | |
Lansing, Michigan, United States, 48910 | |
United States, Missouri | |
St. Louis University, Division of Nephrology | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
University of Rochester, The Center for Vascular Disease | |
Rochester, New York, United States, 14642 | |
NYU Medical Center | |
New York, New York, United States, 10016 | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 | |
St. Luke's Hospital, Department of Surgery | |
New York, New York, United States, 10025 | |
United States, South Carolina | |
Surgical Education | |
Greenville, South Carolina, United States, 29605 | |
United States, Utah | |
University of Utah School of Medicine, Dept of Surgery | |
Salt Lake City, Utah, United States, 84132 | |
United States, Virginia | |
Nephrology Clinical Research Center | |
Charlottesville, Virginia, United States, 22908 |
Study ID Numbers: | CGT003-05 |
Study First Received: | June 25, 2004 |
Last Updated: | July 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00086164 |
Health Authority: | United States: Food and Drug Administration |
edifoligide E2F Decoy Chronic Renal failure |
hemodialysis AV Graft neointimal hyperplasia |
Renal Insufficiency Hyperplasia Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Pathologic Processes |