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
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
1 other identifier
interventional
415
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedMarch 5, 2008
February 1, 2008
2 years
February 26, 2008
March 4, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (1)
To show that AAT-023 (Zuragen) solution is non-inferior to Heparin in terms of patency failure.
6 months
Study Arms (2)
AAT-023 (Zuragen Arm)
EXPERIMENTALActive experimental consisting of AAT-023 (Zuragen)solution
Heparin
ACTIVE COMPARATOR5000 units diluted with normal saline to the exact catheter lumen volume
Interventions
Amount equal to the catheter lumen plus 0.3mL. Three times per week (after each Hemodialysis) for 26 weeks
Hepaarin 5000 units diluted with normal saline to the exact catheter lumen volume.
Eligibility Criteria
You may qualify if:
- End Stage Renal Disease 18 yrs or older.
- CVCD with average dialysis flow rate over 300 mL/min for three most recent visits.
- Expectation by Investigator that CVCD may be needed for up to 26 weeks.
- 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.
- Kt/V \>1.1 or equivalent URR
- Negative serum pregnancy unless surgically sterile or post menopausal for \>1yr.
- Negative blood culture result from pre-enrollment blood sample draw.
- Ability of patient to sign and understand the informed consent.
- Most recent lab results don't indicate hypocalcemia (\<7mg/dL) or thrombocytopenia (\<20,000)
- Avg. systolic blood pressure \>90 mmHg as measured during the most recent three dialysis treatments.
- Lack of signs of current blood stream infection at the beginning of the prior three dialysis treatments.
You may not qualify if:
- A known Heparin allergy or a history of type 2 (antibody mediated) Heparin-induced thrombocytopenia.
- Active bleeding from any site or a documented positive stool hemocult test within 28 days of enrollment in study.
- 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
- Inability to comply with the conditions of, or complete the protocol in the opinion of the Investigator.
- Pregnant or breast feeding.
- Documented allergy to sodium citrate, methylene blue, methyl/paraben and/or propyl paraben.
- 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).
- Malignancy requiring chemotherapy or radiation treatment within 180 days of enrollment.
- 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.
- Contraindications to citrate or taking drugs that may interact with citrate.
- Documented history of glucose-6-phosphate dehydrogenase deficiency (G6PD or Drug-induced methemoglobinemia).
- Participation in another research study.
- 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.
- Unknown priming volume of catheter lumens.
- Redness of over 1 cm diameter or pus around the catheter exit site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Bakersfield Dialysis Center
Bakersfield, California, 93309, United States
Renal Medical Associates
Lynwood, California, 90262, United States
Nephrology & Hypertension Associates, PC
Middlebury, Connecticut, 06762, United States
Brandon nephrology
Brandon, Florida, 33511, United States
Gulf Breeze Dialysis Center
Dunedin, Florida, 34698, United States
Bayonet Point Hudson Kidney Center
Hudson, Florida, 34667, United States
Outcomes Research International, Inc.
Hudson, Florida, 34667, United States
Bay Breeze Dialysis
Largo, Florida, 33778, United States
New Port Richey Kidney Center
New Port Richey, Florida, 34668, United States
Discovery Medical Research Group
Ocala, Florida, 34471, United States
Nephrology consultants
Orlando, Florida, 32806, United States
Hernando Kidney Center
Spring Hill, Florida, 34608, United States
Nephrology Associates, P.C.
Augusta, Georgia, 30901, United States
MId Atlantic Nephrology Associates, PA
Baltimore, Maryland, 21208, United States
Caritas St. Elizabeth Center
Boston, Massachusetts, 02135, United States
Western New England Renal & Transplant Associatea
Springfield, Massachusetts, 01107, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Hypertension & Renal Research Group
Buffalo, New York, 14225, United States
Bayview Nephrology, Inc.
Erie, Pennsylvania, 16507, United States
Kidney Associates, PLLC
Houston, Texas, 77030, United States
Southwest Houston Research, LTD
Houston, Texas, 77099, United States
Fox Valley Nephrology Associates
Appelton, Wisconsin, 54911, United States
Related Publications (1)
Maki DG, Ash SR, Winger RK, Lavin P; AZEPTIC Trial Investigators. A novel antimicrobial and antithrombotic lock solution for hemodialysis catheters: a multi-center, controlled, randomized trial. Crit Care Med. 2011 Apr;39(4):613-20. doi: 10.1097/CCM.0b013e318206b5a2.
PMID: 21200319DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 26, 2008
First Posted
March 5, 2008
Study Start
July 1, 2006
Primary Completion
July 1, 2008
Last Updated
March 5, 2008
Record last verified: 2008-02