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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 | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

NCT00628680•Ash Access Technology

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+5 more criteria

Locations (22)

Bakersfield Dialysis Center

Bakersfield, California, United States

Renal Medical Associates

Lynwood, California, United States

Nephrology & Hypertension Associates, PC

Middlebury, Connecticut, United States

Brandon nephrology

Brandon, Florida, United States

Gulf Breeze Dialysis Center

Dunedin, Florida, 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

New Port Richey Kidney Center

New Port Richey, Florida, United States

Discovery Medical Research Group

Ocala, Florida, United States

Key Dates

Start Date

July 1, 2006

Primary Completion Date

July 1, 2008

Last Updated

March 5, 2008

Enrollment

415

ACTUAL participants

Conditions

End Stage Renal Disease

Interventions

AAT-023 solution (Zuragen)

DEVICE

Heparin

DRUG

EndoForce Post Approval Study

NCT07146854

End Stage Renal Disease (ESRD)

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RECRUITINGNA

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

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End Stage Renal DiseaseHypertension+2 more

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RECRUITINGPHASE2

Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

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