Clinical trial NCT00628680: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: End Stage Renal Disease
Keywords: Renal Disease
Kidney Failure
End Stage Renal Disease
Lead sponsor: Ash Access Technology
Sponsor class: INDUSTRY
First posted: 2008-03-05
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: To show that AAT-023 (Zuragen) solution is non-inferior to Heparin in terms of patency failure.
timeFrame: 6 months
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Bakersfield Dialysis Center
state: California
city: Lynwood
country: United States
facility: Renal Medical Associates
state: California
city: Middlebury
country: United States
facility: Nephrology & Hypertension Associates, PC
state: Connecticut
city: Brandon
country: United States
facility: Brandon nephrology
state: Florida
city: Dunedin
country: United States
facility: Gulf Breeze Dialysis Center
state: Florida
city: Hudson
country: United States
facility: Bayonet Point Hudson Kidney Center
state: Florida
city: Hudson
country: United States
facility: Outcomes Research International, Inc.
state: Florida
city: Largo
country: United States
facility: Bay Breeze Dialysis
state: Florida
city: New Port Richey
country: United States
facility: New Port Richey Kidney Center
state: Florida
city: Ocala
country: United States
facility: Discovery Medical Research Group
state: Florida
city: Orlando
country: United States
facility: Nephrology consultants
state: Florida
city: Spring Hill
country: United States
facility: Hernando Kidney Center
state: Florida
city: Augusta
country: United States
facility: Nephrology Associates, P.C.
state: Georgia
city: Baltimore
country: United States
facility: MId Atlantic Nephrology Associates, PA
state: Maryland
city: Boston
country: United States
facility: Caritas St. Elizabeth Center
state: Massachusetts
city: Springfield
country: United States
facility: Western New England Renal & Transplant Associatea
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Buffalo
country: United States
facility: Hypertension & Renal Research Group
state: New York
city: Erie
country: United States
facility: Bayview Nephrology, Inc.
state: Pennsylvania
city: Houston
country: United States
facility: Kidney Associates, PLLC
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research, LTD
state: Texas
city: Appelton
country: United States
facility: Fox Valley Nephrology Associates
state: Wisconsin
Study officials:
References:
citation: 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.