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Sponsored by: |
Ash Access Technology |
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Information provided by: | Ash Access Technology |
ClinicalTrials.gov Identifier: | NCT00628680 |
The purpose of this study is to determine if AAT-023 (Zuragen) solution is superior to Heparin in preventing Catheter Related Blood Stream Infections for End Stage Renal Disease patients.
Condition | Intervention | Phase |
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End Stage Renal Disease |
Device: AAT-023 solution (Zuragen) Drug: Heparin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Pivotal/Phase III Multicentered, Two-Arm, Randomized Study Comparing the Effects of AAT-023 Solution (Zuragen), and Heparin on the Incidence of Catheter Related Blood Stream Infections in Tunneled Chronic Central Venous Catheters for Dialysis |
Enrollment: | 415 |
Study Start Date: | July 2006 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AAT-023 (Zuragen Arm): Experimental
Active experimental consisting of AAT-023 (Zuragen)solution
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Device: AAT-023 solution (Zuragen)
Amount equal to the catheter lumen plus 0.3mL. Three times per week (after each Hemodialysis) for 26 weeks
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Heparin: Active Comparator
5000 units diluted with normal saline to the exact catheter lumen volume
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Drug: Heparin
Hepaarin 5000 units diluted with normal saline to the exact catheter lumen volume.
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The purpose of this study is to show that AAT-023 (Zuragen) Solution is superior to Heparin in preventing Catheter Related Blood Stream Infections (CRBSI) when used as a catheter lock solution in Central Venous Catheter's for Dialysis between hemodialysis treatments (3x per week), where CRBSI's are defined as concordant bacteria found in both the catheter and peripheral blood or the exit site and peripheral blood in subjects demonstrating a temperature greater than 38 degrees celcius.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Bakersfield Dialysis Center | |
Bakersfield, California, United States, 93309 | |
Renal Medical Associates | |
Lynwood, California, United States, 90262 | |
United States, Connecticut | |
Nephrology & Hypertension Associates, PC | |
Middlebury, Connecticut, United States, 06762 | |
United States, Florida | |
Outcomes Research International, Inc. | |
Hudson, Florida, United States, 34667 | |
Hernando Kidney Center | |
Spring Hill, Florida, United States, 34608 | |
Brandon nephrology | |
Brandon, Florida, United States, 33511 | |
Bayonet Point Hudson Kidney Center | |
Hudson, Florida, United States, 34667 | |
Gulf Breeze Dialysis Center | |
Dunedin, Florida, United States, 34698 | |
Bay Breeze Dialysis | |
Largo, Florida, United States, 33778 | |
Discovery Medical Research Group | |
Ocala, Florida, United States, 34471 | |
New Port Richey Kidney Center | |
New Port Richey, Florida, United States, 34668 | |
Nephrology consultants | |
Orlando, Florida, United States, 32806 | |
United States, Georgia | |
Nephrology Associates, P.C. | |
Augusta, Georgia, United States, 30901 | |
United States, Maryland | |
MId Atlantic Nephrology Associates, PA | |
Baltimore, Maryland, United States, 21208 | |
United States, Massachusetts | |
Western New England Renal & Transplant Associatea | |
Springfield, Massachusetts, United States, 01107 | |
Caritas St. Elizabeth Center | |
Boston, Massachusetts, United States, 02135 | |
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, New York | |
Hypertension & Renal Research Group | |
Buffalo, New York, United States, 14225 | |
United States, Pennsylvania | |
Bayview Nephrology, Inc. | |
Erie, Pennsylvania, United States, 16507 | |
United States, Texas | |
Kidney Associates, PLLC | |
Houston, Texas, United States, 77030 | |
Southwest Houston Research, LTD | |
Houston, Texas, United States, 77099 | |
United States, Wisconsin | |
Fox Valley Nephrology Associates | |
Appelton, Wisconsin, United States, 54911 |
Responsible Party: | Ash Access Technology ( Roland Winger, VP of Clinical and Product Development ) |
Study ID Numbers: | AATML2003-A |
Study First Received: | February 26, 2008 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00628680 |
Health Authority: | United States: Food and Drug Administration |
Renal Disease Kidney Failure End Stage Renal Disease |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Kidney Diseases Heparin Calcium heparin Kidney Failure |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |