Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00628680
Recruitment Status : Unknown
Verified February 2008 by Ash Access Technology.
Recruitment status was:  Active, not recruiting
First Posted : March 5, 2008
Last Update Posted : March 5, 2008
Sponsor:
Information provided by:
Ash Access Technology

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Device: AAT-023 solution (Zuragen) Drug: Heparin Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : July 2006
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. To show that AAT-023 (Zuragen) solution is non-inferior to Heparin in terms of patency failure. [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628680


Locations
Show Show 22 study locations
Sponsors and Collaborators
Ash Access Technology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Roland Winger, VP of Clinical and Product Development, Ash Access Technology
ClinicalTrials.gov Identifier: NCT00628680    
Other Study ID Numbers: AATML2003-A
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: March 5, 2008
Last Verified: February 2008
Keywords provided by Ash Access Technology:
Renal Disease
Kidney Failure
End Stage Renal Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Sepsis
Kidney Diseases
Kidney Failure, Chronic
Infections
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action