Efficacy Study to Evaluate B-Lock™ as an Antimicrobial Lock Solution in Dialysis Patients With a CVC

This study is currently recruiting participants.
Verified November 2013 by Great Lakes Pharmaceuticals Inc.
Sponsor:
Information provided by (Responsible Party):
Great Lakes Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01989091
First received: October 30, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

Hypothesis: B-Lock is a safe and effective catheter lock solution that will maintain catheter patency and reduce Central Line Associated Blood Stream Infections (CLABSI) in dialysis patients using a central venous catheter (CVC) for vascular access.

The study is a prospective, randomized, site unblinded/sponsor blinded, clinical study of a minimum of 300 dialysis patients using a central venous catheter (CVC) for vascular access. Patients will be randomized 1:1 to receive either the investigational medical device (B-Lock or IMD) or active control heparin (5000 U/mL) (ACH) and observed for a minimum of 45 days or a maximum of 273 (expected average 160 days). IMD or ACH will be instilled into the catheter lumens (dual lumen catheters) at the end of each dialysis session and removed prior to the initiation of the next dialysis session.

The primary objectives of this study are:

  • To demonstrate the safety of B-Lock in dialysis patients
  • To demonstrate the non-inferiority or, if proven to be non-inferior, superiority of B-Lock relative to ACH with respect to maintaining catheter patency as defined by the use of recombinant tissue plasminogen activator for maintaining adequate blood flow through the dialysis catheter
  • To demonstrate the superiority of B-Lock relative to ACH with respect to the incidence of CLABSI

Condition Intervention Phase
Dialysis Catheter Infections
Device: B-Lock
Drug: Heparin 5,000 U/mL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multi-Center, Prospective, Randomized, Open-Label, Sponsor-Blinded, Active-Control (Heparin) Clinical Investigation to Evaluate the Safety and Effectiveness of B-Lock™ as an Antimicrobial Catheter Lock Solution in Dialysis Patients With a Central Venous Catheter

Resource links provided by NLM:


Further study details as provided by Great Lakes Pharmaceuticals Inc.:

Primary Outcome Measures:
  • The number of adverse events (AEs), serious adverse events (SAEs) and device deficiencies (DDs) in the experimental and control populations [ Time Frame: 39 weeks ] [ Designated as safety issue: Yes ]
  • The number of thrombolytic treatment events in the experimental and control populations. [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
    Thrombolytic treatments may be required to maintain catheter blood flow rates when blood flow is measured under standardized conditions and compared to blood flow at study entry. The number of treatment events in the experimental and control populations is inversely related to the ability of the lock solution to maintain catheter patency.

  • The number of Central Line Associated Blood Stream Infections (CLABSI events) in the experimental and control populations. [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
    CLABSI is defined by the CDC as a documented blood stream infection (bacterial or fungal) in a patient with a CVC with no other source of infection identified by a qualified physician.


Secondary Outcome Measures:
  • The number of Lock Solution Failures in the experimental and control populations. [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
    "Lock Solution Failure" is defined as the sum of CLABSI events plus Occlusive Malfunction events. Occlusive malfunction is defined as the inability to return catheter blood flow rates to greater than 80% of baseline blood flow measrued at study entry under standardized conditions after treatment with tissue plasminogen activator (thrombolytic treatment).

  • The number of Occlusive Malfunction events in the experimental and control populations. [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
  • The number of lock solution aspirate cultures that are positive for bacterial or fungal growth in the experimental and control populations. [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
  • The number of catheters removed from the experimental and control patients that are found to have bacterial or fungal biofilm present inside the catheter lumen(s). [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
  • Catheter blood flow rates measured under standardized conditions over the duration of the study in the experimental and control populations. [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B-Lock (IMD)
Investigational Medical Device (IMD)
Device: B-Lock
Antimicrobial Catheter Lock Solution
Other Name: IMD
Active Comparator: Heparin 5,000 U/mL (ACH)
Active Comparator Heparin (ACH)
Drug: Heparin 5,000 U/mL
Standard of Care Catheter Lock Solution
Other Name: ACH

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients age 18 to 80 years, inclusive. Patients, age 81 to 85 years, inclusive, may be included on a case-by-case basis if their health status is determined to be stable after consultation with the Medical Monitor.
  • Patients with end-stage renal disease receiving hemodialysis via CVC.
  • Patients must be expected to receive hemodialysis through a direct or cuffed, tunneled dual lumen catheter or 2 cuffed, tunneled single lumen catheters for a minimum of 45 catheter-days after Day 1.
  • Patients must have been receiving dialysis for a minimum of 6 dialysis sessions at the study center dialysis clinic prior to the signing of the Informed Consent Form (ICF).
  • Patients must have received dialysis at their prescribed blood flow rate (+/- 10%) for at least 2 consecutive dialysis sessions prior to signing the ICF.
  • Patients must have 2 screening pre-pump arterial pressure measurements (collected during the first 20 minutes of dialysis) that differ by less than or equal to (≤) 20 mmHg at 2 consecutive dialysis sessions when receiving dialysis at their prescribed blood flow rate (+/- 10%) prior to randomization.

Exclusion Criteria:

  • Clinical signs and/or symptoms of a local or systemic infection within 14 days prior to Day 1.
  • Evidence of infection of the catheter exit site/tunnel within 14 days prior to Day 1.
  • Patients who have received systemic antibiotics within 14 days prior to Day 1.
  • History of fever (T > 37.5°C) or chills within 14 days prior to Day 1.
  • An occluded catheter (blood flow inadequate for dialysis) or a catheter that required thrombolytic treatment within 14 days prior to Day 1.
  • A catheter coated or impregnated with an antithrombotic, antimicrobial or antiseptic agent, including heparin.
  • A catheter coated or impregnated with an antithrombotic, antimicrobial or antiseptic agent, including heparin.
  • Catheters that are deemed by their manufacturers to be incompatible with alcohol-containing solutions. These include, but are not limited to:

    1. Angiodynamics - LifeJet® VP VascPak Catheter.
    2. Angiodynamics - Schon™ Chronic Hemodialysis Catheter.
    3. Angiotech - Hemostream™ Chronic Dialysis Catheter.
    4. Bard - all Bard Catheters.
  • The use of TEGO® or TEGO-like catheter caps. Patients may be switched to standard catheter caps in order to participate in this study.
  • Patients with a known or documented allergy to TMP or TMP-containing drugs, ethanol, ethylene diamine tetraacetic acid (EDTA), propylene glycol and/or glycerin.
  • Patients with a history of heparin-induced thrombocytopenia or in whom the use of heparin is contraindicated. (Note: If the use of heparin is restricted for only a specified period of time, the patient may be enrolled at a later date when the use of heparin is no longer contraindicated.)
  • Evidence of acute/ongoing hepatic injury (alanine aminotransferase [ALT] > 300 IU/L) or chronic hepatic insufficiency (Total bilirubin > 2.0 mg/dL and/or albumin < 3.0 g/dL during Screening or within 30 days prior to Screening). Note: A patient whose albumin level is low solely due to nephrotic syndrome may be enrolled (with Medical Monitor approval) if the albumin level has been stable for at least 3 months prior to ICF signature.
  • Patients who the Investigator believes have a prognosis for survival of less than 3 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01989091

Contacts
Contact: John C Cheronis, MD PhD 303-435-4074 jcheronis@glpharma.com
Contact: Susan Johnson, RPh 303-257-9542 sjohnson@glpharma.com

Locations
Hungary
FMC Szépvölgyi Dialízis Központ Recruiting
Budapest, Hungary
Contact: Ottó Árkossy, MD    36 20 9676226    otto.arkossy@fmc-ag.com   
Principal Investigator: Ottó Árkossy, MD         
FMC Dialízis Központ Péterfy S. Kórház Recruiting
Budapest, Hungary
Contact: Csaba Rikker, MD    36 20 8047801    csaba.rikker@fmc-ag.com   
Principal Investigator: Csaba Rikker, MD         
FMC Dialízis Központ Szent István Kórház Recruiting
Budapest, Hungary
Contact: Judit Harsányi, MD    36 70 8667990    judit.harsanyi@fmc-ag.com   
Principal Investigator: Judit Harsányi, MD         
DE OEC Nephrologiai Tanszék Recruiting
Debrecen, Hungary
Contact: József Balla, MD    36 52 413 653    balla@internal.med.unideb.hu   
Principal Investigator: József Balla, MD         
FMC Dialízis Központ Eger Recruiting
Eger, Hungary
Contact: Péter Nagy, MD    36 70 376 8923    peter.nagy@fmc-ag.com   
Principal Investigator: Péter Nagy, MD         
FMC Dialízis Központ Kecskemét Recruiting
Kecskémet, Hungary
Contact: Sándor Keresztesi, MD    36 20 439 6543    sandor.keresztesi@fmc-ag.com   
Principal Investigator: Sandor Keresztesi, MD         
FMC Nefrológiai Központ Miskolc Recruiting
Miskolc, Hungary
Contact: Erzsébet Ladányi, MD    36 20 954 1177    erzsebet.ladanyi@fmc-ag.com   
Principal Investigator: Erzsébet Ladányi, MD         
FMC Dialízis Központ Pécs Suspended
Pécs, Hungary
FMC Szatellita Dialízis Központ Pécs Suspended
Pécs, Hungary
Szegedi Tudományegyetem Recruiting
Szeged, Hungary
Contact: Zoltán Ondrik, MD    36 202 533 732    zoltan.ondrik@gmail.com   
Principal Investigator: Zoltan Ondrik, MD         
Poland
Stacja Dializ w NZOZ Centrum Chorób Wewnętrzynych "EL-VITA" w Elblągu Recruiting
Elbląg, Poland
Contact: Adam Majewski, MD    48 698417793    adam.majewski@avitum.com.pl   
Principal Investigator: Adam Majewski, MD         
Uniwersyteckie Centrum Kliniczne, Klinika Nefrologii, Transplantologii i Chorób Wewn Recruiting
Gdansk, Poland
Contact: Bolesław Rutkowski, MD    48 58 349 2505    bolo@gumed.edu.pl   
Principal Investigator: Bolesław Rutkowski, MD         
Stacja Dializ NZOZ Diaverum Recruiting
Gdansk, Poland
Contact: Przemysław Rutkowski, MD    48 664479338    przemyslaw.rutkowski@diaverum.com   
Principal Investigator: Przemysław Rutkowski, MD         
Niepubliczny Zakład Opieki Zdrowotnej Diaverum Gdańsk Kartuska, Stacja Dializ Recruiting
Gdańsk, Poland
Contact: Przemysław Rutkowski, MD    48 664479338    przemyslaw.rutkowski@diaverum.com   
Principal Investigator: Przemysław Rutkowski, MD         
Stacja Dializ NZOZ Avitum w Legnicy Recruiting
Legnica, Poland
Contact: Adam Drozd, MD    48 509013512    adam.drozd@avitum.com.pl   
Principal Investigator: Adam Drozd, MD         
Stacja Dializ NZOZ Avitum w Miechowie Recruiting
Miechów, Poland
Contact: Marek Kolarz, MD    48 602759895    marek.kolarz@avitum.com.pl   
Principal Investigator: Marek Kolarz, MD         
Szpital Kliniczny im. H. Święcickiego, Oddział Nefrologii, Pododdział Dializ Recruiting
Poznań, Poland
Contact: Andrzej Oko, MD    48 61 8691605    aoko@ump.edu.pl   
Principal Investigator: Andrzej Oko, MD         
Radomski Szpital Specjalistyczny im. T. Chałubińskiego, Oddział Dializ Suspended
Radom, Poland
Stacja Dializ NZOZ Diaverum w Tczewie Recruiting
Tczew, Poland
Contact: Przemysław Rutkowski, MD    48 662245690    przemyslaw.rutkowski@diaverum.com   
Principal Investigator: Przemysław Rutkowski, MD         
Stacja Dializ NZOZ Avitum w Zgierzu Recruiting
Zgierz, Poland
Contact: Janusz Wyroślak    48 604789624    janusz.wyroslak@avitum.com.pl   
Principal Investigator: Janusz Wyroślak, MD         
Uniw. Szpital Kliniczny im. N.Barlickiego,Oddział Nefrologii, Pododdział Dializ Recruiting
Łódź, Poland
Contact: Michał Nowicki, MD    48 601561664    nefro@wp.pl   
Principal Investigator: Michał Nowicki, MD         
Sponsors and Collaborators
Great Lakes Pharmaceuticals Inc.
Investigators
Study Director: John C Cheronis, MD PhD Great Lakes Pharmaceuticals Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Great Lakes Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01989091     History of Changes
Other Study ID Numbers: GL-CL-0001
Study First Received: October 30, 2013
Last Updated: November 14, 2013
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Hungary: National Institute of Pharmacy

Keywords provided by Great Lakes Pharmaceuticals Inc.:
kidney dialysis
hemodialysis
locking solution
antimicrobial
thrombolytic

Additional relevant MeSH terms:
Anti-Infective Agents
Calcium heparin
Heparin
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014