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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00628680
• Other study ID #: AATML2003-A
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 26, 2008
• Last updated: March 4, 2008
• Start date: July 2006

Study information

• Verified date: February 2008
• Source: Ash Access Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 415
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• AAT-023 solution (Zuragen)
Amount equal to the catheter lumen plus 0.3mL. Three times per week (after each Hemodialysis) for 26 weeks

Drug:
• Heparin
Hepaarin 5000 units diluted with normal saline to the exact catheter lumen volume.

Locations

Country	Name	City	State
United States	Fox Valley Nephrology Associates	Appelton	Wisconsin
United States	Nephrology Associates, P.C.	Augusta	Georgia
United States	Bakersfield Dialysis Center	Bakersfield	California
United States	MId Atlantic Nephrology Associates, PA	Baltimore	Maryland
United States	Caritas St. Elizabeth Center	Boston	Massachusetts
United States	Brandon nephrology	Brandon	Florida
United States	Hypertension & Renal Research Group	Buffalo	New York
United States	Henry Ford Hospital	Detroit	Michigan
United States	Gulf Breeze Dialysis Center	Dunedin	Florida
United States	Bayview Nephrology, Inc.	Erie	Pennsylvania
United States	Kidney Associates, PLLC	Houston	Texas
United States	Southwest Houston Research, LTD	Houston	Texas
United States	Bayonet Point Hudson Kidney Center	Hudson	Florida
United States	Outcomes Research International, Inc.	Hudson	Florida
United States	Bay Breeze Dialysis	Largo	Florida
United States	Renal Medical Associates	Lynwood	California
United States	Nephrology & Hypertension Associates, PC	Middlebury	Connecticut
United States	New Port Richey Kidney Center	New Port Richey	Florida
United States	Discovery Medical Research Group	Ocala	Florida
United States	Nephrology consultants	Orlando	Florida
United States	Hernando Kidney Center	Spring Hill	Florida
United States	Western New England Renal & Transplant Associatea	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Ash Access Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To show that AAT-023 (Zuragen) solution is non-inferior to Heparin in terms of patency failure.		6 months	No