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

March 4, 2008 updated by: Ash Access Technology

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
415

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Bakersfield Dialysis Center
      • Lynwood, California, United States, 90262
        • Renal Medical Associates
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Nephrology & Hypertension Associates, PC
    • Florida
      • Brandon, Florida, United States, 33511
        • Brandon nephrology
      • Dunedin, Florida, United States, 34698
        • Gulf Breeze Dialysis Center
      • Hudson, Florida, United States, 34667
        • Outcomes Research International, Inc.
      • Hudson, Florida, United States, 34667
        • Bayonet Point Hudson Kidney Center
      • Largo, Florida, United States, 33778
        • Bay Breeze Dialysis
      • New Port Richey, Florida, United States, 34668
        • New Port Richey Kidney Center
      • Ocala, Florida, United States, 34471
        • Discovery Medical Research Group
      • Orlando, Florida, United States, 32806
        • Nephrology Consultants
      • Spring Hill, Florida, United States, 34608
        • Hernando Kidney Center
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Nephrology Associates, P.C.
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • MId Atlantic Nephrology Associates, PA
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Caritas St. Elizabeth Center
      • Springfield, Massachusetts, United States, 01107
        • Western New England Renal & Transplant Associatea
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New York
      • Buffalo, New York, United States, 14225
        • Hypertension & Renal Research Group
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Bayview Nephrology, Inc.
    • Texas
      • Houston, Texas, United States, 77030
        • Kidney Associates, PLLC
      • Houston, Texas, United States, 77099
        • Southwest Houston Research, Ltd
    • Wisconsin
      • Appelton, Wisconsin, United States, 54911
        • Fox Valley Nephrology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To show that AAT-023 (Zuragen) solution is non-inferior to Heparin in terms of patency failure.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ash Access Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AATML2003-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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