A Multi-Centered, Two-Arm, Randomized Study Comparing the Effects of AAT-023 (Zuragen) Solution, and Heparin on the Incidence of Catheter Related Blood Stream Infections in Tunneled Chronic Central Venous Catheters for Dialysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Ash Access Technology.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ash Access Technology
ClinicalTrials.gov Identifier:
NCT00628680
First received: February 26, 2008
Last updated: March 4, 2008
Last verified: February 2008
  Purpose

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
End Stage Renal Disease
Device: AAT-023 solution (Zuragen)
Drug: Heparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Ash Access Technology:

Primary Outcome Measures:
  • To show that AAT-023 (Zuragen) solution is superior to Heparin in preventing CRBSI when used as a catheter lock solution in CVCD's between hemodialysis treatments. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To show that AAT-023 (Zuragen) solution is non-inferior to Heparin in terms of patency failure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 415
Study Start Date: July 2006
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AAT-023 (Zuragen Arm)
Active experimental consisting of AAT-023 (Zuragen)solution
Device: AAT-023 solution (Zuragen)
Amount equal to the catheter lumen plus 0.3mL. Three times per week (after each Hemodialysis) for 26 weeks
Active Comparator: Heparin
5000 units diluted with normal saline to the exact catheter lumen volume
Drug: Heparin
Hepaarin 5000 units diluted with normal saline to the exact catheter lumen volume.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. End Stage Renal Disease 18 yrs or older.
  2. CVCD with average dialysis flow rate over 300 mL/min for three most recent visits.
  3. Expectation by Investigator that CVCD may be needed for up to 26 weeks.
  4. Dialysis catheter is of three types a) single body with single entry and exit, b) single body with split ends, c) twin catheter with one catheter for removal of blood and another for return.
  5. Kt/V >1.1 or equivalent URR
  6. Negative serum pregnancy unless surgically sterile or post menopausal for >1yr.
  7. Negative blood culture result from pre-enrollment blood sample draw.
  8. Ability of patient to sign and understand the informed consent.
  9. Most recent lab results don't indicate hypocalcemia (<7mg/dL) or thrombocytopenia (<20,000)
  10. Avg. systolic blood pressure >90 mmHg as measured during the most recent three dialysis treatments.
  11. Lack of signs of current blood stream infection at the beginning of the prior three dialysis treatments.

Exclusion Criteria:

  1. A known Heparin allergy or a history of type 2 (antibody mediated) Heparin-induced thrombocytopenia.
  2. Active bleeding from any site or a documented positive stool hemocult test within 28 days of enrollment in study.
  3. Bloodstream infection,exit site infection or any infection requiring antibiotic use within 14 days of enrollment for any antibiotic listed in section 4.2.3 or within 30 days of enrollment for Vancomycin or any other antibiotic not listed in section 4.2.3 of the protocol
  4. Inability to comply with the conditions of, or complete the protocol in the opinion of the Investigator.
  5. Pregnant or breast feeding.
  6. Documented allergy to sodium citrate, methylene blue, methyl/paraben and/or propyl paraben.
  7. Documented chronic intrinsic coagulopathy evidenced by persistently and significantly elevated Prothrombin (INR>3), Partial Thromboplastin Time (PTT>60 seconds), or thrombocytopenia (platlet count <20,000/mm).
  8. Malignancy requiring chemotherapy or radiation treatment within 180 days of enrollment.
  9. Documented requirement for >5,000 units of Heparin per catheter lumen to maintain catheter patency (with decrease in blood flow demonstrated at 5,000 units per lumen Heparin catheter lock) with current catheter.
  10. Contraindications to citrate or taking drugs that may interact with citrate.
  11. Documented history of glucose-6-phosphate dehydrogenase deficiency (G6PD or Drug-induced methemoglobinemia).
  12. Participation in another research study.
  13. Co-morbidities, such as HIV, active hepatitis or recent transplants, that in the opinion of the Investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results and would make the subject inappropriate for entry into this study.
  14. Unknown priming volume of catheter lumens.
  15. Redness of over 1 cm diameter or pus around the catheter exit site.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628680

Locations
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
Brandon nephrology
Brandon, Florida, United States, 33511
Gulf Breeze Dialysis Center
Dunedin, Florida, United States, 34698
Outcomes Research International, Inc.
Hudson, Florida, United States, 34667
Bayonet Point Hudson Kidney Center
Hudson, Florida, United States, 34667
Bay Breeze Dialysis
Largo, Florida, United States, 33778
New Port Richey Kidney Center
New Port Richey, Florida, United States, 34668
Discovery Medical Research Group
Ocala, Florida, United States, 34471
Nephrology consultants
Orlando, Florida, United States, 32806
Hernando Kidney Center
Spring Hill, Florida, United States, 34608
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
Caritas St. Elizabeth Center
Boston, Massachusetts, United States, 02135
Western New England Renal & Transplant Associatea
Springfield, Massachusetts, United States, 01107
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
Sponsors and Collaborators
Ash Access Technology
  More Information

No publications provided by Ash Access Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roland Winger, VP of Clinical and Product Development, Ash Access Technology
ClinicalTrials.gov Identifier: NCT00628680     History of Changes
Other Study ID Numbers: AATML2003-A
Study First Received: February 26, 2008
Last Updated: March 4, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Ash Access Technology:
Renal Disease
Kidney Failure
End Stage Renal Disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Calcium heparin
Heparin
Pharmaceutical Solutions
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014