End Stage Renal DiseasePhase 3NCT00628680
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
A Phase 3 study testing AAT-023 solution (Zuragen) and Heparin in people with End Stage Renal Disease, run by Ash Access Technology at 22 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- AAT-023 solution (Zuragen) and Heparin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 22 sitesUnited States
- Study dates
- Jul 2006to Jul 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End Stage Renal Disease 18 yrs or older.
- CVCD with average dialysis flow rate over 300 mL/min for three most recent visits.
- Expectation by Investigator that CVCD may be needed for up to 26 weeks.
- 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.
- Kt/V >1.1 or equivalent URR
- Negative serum pregnancy unless surgically sterile or post menopausal for >1yr.
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- Negative blood culture result from pre-enrollment blood sample draw.
- Ability of patient to sign and understand the informed consent.
- Most recent lab results don't indicate hypocalcemia (<7mg/dL) or thrombocytopenia (<20,000)
- Avg. systolic blood pressure >90 mmHg as measured during the most recent three dialysis treatments.
- Lack of signs of current blood stream infection at the beginning of the prior three dialysis treatments.
Who cannot join
- A known Heparin allergy or a history of type 2 (antibody mediated) Heparin-induced thrombocytopenia.
- Active bleeding from any site or a documented positive stool hemocult test within 28 days of enrollment in study.
- 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
- Inability to comply with the conditions of, or complete the protocol in the opinion of the Investigator.
- Pregnant or breast feeding.
- Documented allergy to sodium citrate, methylene blue, methyl/paraben and/or propyl paraben.
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- 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).
- Malignancy requiring chemotherapy or radiation treatment within 180 days of enrollment.
- 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.
- Contraindications to citrate or taking drugs that may interact with citrate.
- Documented history of glucose-6-phosphate dehydrogenase deficiency (G6PD or Drug-induced methemoglobinemia).
- Participation in another research study.
- 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.
- Unknown priming volume of catheter lumens.
- Redness of over 1 cm diameter or pus around the catheter exit site.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Fox Valley Nephrology Associates
Appelton, Wisconsin, 54911
Nephrology Associates, P.C.
Augusta, Georgia, 30901
Bakersfield Dialysis Center
Bakersfield, California, 93309
MId Atlantic Nephrology Associates, PA
Baltimore, Maryland, 21208
Caritas St. Elizabeth Center
Boston, Massachusetts, 02135
Brandon nephrology
Brandon, Florida, 33511
Hypertension & Renal Research Group
Buffalo, New York, 14225
Henry Ford Hospital
Detroit, Michigan, 48202
Gulf Breeze Dialysis Center
Dunedin, Florida, 34698
Bayview Nephrology, Inc.
Erie, Pennsylvania, 16507
Kidney Associates, PLLC
Houston, Texas, 77030
Southwest Houston Research, LTD
Houston, Texas, 77099
Bayonet Point Hudson Kidney Center
Hudson, Florida, 34667
Outcomes Research International, Inc.
Hudson, Florida, 34667
Bay Breeze Dialysis
Largo, Florida, 33778
Renal Medical Associates
Lynwood, California, 90262
Nephrology & Hypertension Associates, PC
Middlebury, Connecticut, 06762
New Port Richey Kidney Center
New Port Richey, Florida, 34668
Discovery Medical Research Group
Ocala, Florida, 34471
Nephrology consultants
Orlando, Florida, 32806
Hernando Kidney Center
Spring Hill, Florida, 34608
Western New England Renal & Transplant Associatea
Springfield, Massachusetts, 01107
About this study
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
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.
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- AAT-023 solution (Zuragen), Heparin
- Keywords
- Renal Disease, Kidney Failure, End Stage Renal Disease
- Medical subject headings
- Kidney Failure, Chronic, Kidney Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAT-023 solution (Zuragen)Device
Amount equal to the catheter lumen plus 0.3mL. Three times per week (after each Hemodialysis) for 26 weeks
HeparinDrug
Hepaarin 5000 units diluted with normal saline to the exact catheter lumen volume.
| Study group | Role | What they receive |
|---|---|---|
| AAT-023 (Zuragen Arm) | Experimental | Active experimental consisting of AAT-023 (Zuragen)solution Receives: Device: AAT-023 solution (Zuragen) |
| Heparin | Active comparator | 5000 units diluted with normal saline to the exact catheter lumen volume Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
To show that AAT-023 (Zuragen) solution is non-inferior to Heparin in terms of patency failure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJul 2006
- Primary completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ash Access Technology
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628680
- Sponsor's protocol ID
- AATML2003-A
- Status last verified
- Feb 2008
- First submitted
- 26 Feb 2008
- Last updated
- 5 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21200319
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00628680
- Acronym / sponsor ID
- AATML2003-A
- Conditions
- End Stage Renal Disease
- Keywords
- Renal Disease, Kidney Failure, End Stage Renal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Ash Access TechnologyIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jul 2008 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAT-023 (Zuragen Arm) | Experimental | Device: AAT-023 solution (Zuragen)Active experimental consisting of AAT-023 (Zuragen)solution |
| Heparin | Active comparator | Drug: Heparin5000 units diluted with normal saline to the exact catheter lumen volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- End Stage Renal Disease 18 yrs or older.
- CVCD with average dialysis flow rate over 300 mL/min for three most recent visits.
- Expectation by Investigator that CVCD may be needed for up to 26 weeks.
- 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.
- Kt/V >1.1 or equivalent URR
Key exclusion criteria (15 listed)
- A known Heparin allergy or a history of type 2 (antibody mediated) Heparin-induced thrombocytopenia.
- Active bleeding from any site or a documented positive stool hemocult test within 28 days of enrollment in study.
- 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
- Inability to comply with the conditions of, or complete the protocol in the opinion of the Investigator.
- Pregnant or breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAT-023 solution (Zuragen)Amount equal to the catheter lumen plus 0.3mL. Three times per week (after each Hemodialysis) for 26 weeks | Device | AAT-023 (Zuragen Arm) |
| HeparinHepaarin 5000 units diluted with normal saline to the exact catheter lumen volume. | Drug | Heparin |
Primary outcome
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
1 secondary outcome
To show that AAT-023 (Zuragen) solution is non-inferior to Heparin in terms of patency failure.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2008.
- Derived from this study: PubMed 21200319Maki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AAT-023 solution (Zuragen) and Heparin in people with End Stage Renal Disease, run by Ash Access Technology at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00628680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2008.