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

NCT01989091 | Terminated Phase 3 DMC

• 1 other identifier: GL-CL-0001
• Study Type: interventional
• Target: 270
• Locations: 2 countries
• Sites: 21

Brief Summary

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

Conditions

Dialysis Catheter Infections

Keywords

kidney dialysis; hemodialysis; locking solution; antimicrobial; thrombolytic

Outcome Measures

Primary Outcomes (3)

• The number of adverse events (AEs), serious adverse events (SAEs) and device deficiencies (DDs) in the experimental and control populations

  39 weeks

• The number of thrombolytic treatment events in the experimental and control populations.

  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.

  39 weeks

• The number of Central Line Associated Blood Stream Infections (CLABSI events) in the experimental and control populations.

  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.

  39 weeks

Secondary Outcomes (5)

• The number of Lock Solution Failures in the experimental and control populations.

  39 weeks

• The number of Occlusive Malfunction events in the experimental and control populations.

  39 weeks

• The number of lock solution aspirate cultures that are positive for bacterial or fungal growth in the experimental and control populations.

  39 weeks

• 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).

  39 weeks

• Catheter blood flow rates measured under standardized conditions over the duration of the study in the experimental and control populations.

  39 weeks

Study Arms (2)

B-Lock (IMD)

EXPERIMENTAL

Investigational Medical Device (IMD)

Device: B-Lock

Heparin 5,000 U/mL (ACH)

ACTIVE COMPARATOR

Active Comparator Heparin (ACH)

Drug: Heparin 5,000 U/mL

Interventions

B-Lock DEVICE

Antimicrobial Catheter Lock Solution

Also known as: IMD

B-Lock (IMD)

Heparin 5,000 U/mL DRUG

Standard of Care Catheter Lock Solution

Also known as: ACH

Heparin 5,000 U/mL (ACH)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Angiodynamics - LifeJet® VP VascPak Catheter.
• Angiodynamics - Schon™ Chronic Hemodialysis Catheter.
• Angiotech - Hemostream™ Chronic Dialysis Catheter.
• 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.)

Sponsors & Collaborators

• Great Lakes Pharmaceuticals Inc.: lead

Study Sites (21)

FMC Dialízis Központ Péterfy S. Kórház

Budapest, Hungary

Location

FMC Dialízis Központ Szent István Kórház

Budapest, Hungary

Location

FMC Szépvölgyi Dialízis Központ

Budapest, Hungary

Location

DE OEC Nephrologiai Tanszék

Debrecen, Hungary

Location

FMC Dialízis Központ Eger

Eger, Hungary

Location

FMC Dialízis Központ Kecskemét

Kecskémet, Hungary

Location

FMC Nefrológiai Központ Miskolc

Miskolc, Hungary

Location

FMC Dialízis Központ Pécs

Pécs, Hungary

Location

FMC Szatellita Dialízis Központ Pécs

Pécs, Hungary

Location

Szegedi Tudományegyetem

Szeged, Hungary

Location

Stacja Dializ w NZOZ Centrum Chorób Wewnętrzynych "EL-VITA" w Elblągu

Elblag, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej Diaverum Gdańsk Kartuska, Stacja Dializ

Gdansk, Poland

Location

Stacja Dializ NZOZ Diaverum

Gdansk, Poland

Location

Uniwersyteckie Centrum Kliniczne, Klinika Nefrologii, Transplantologii i Chorób Wewn

Gdansk, Poland

Location

Stacja Dializ NZOZ Avitum w Legnicy

Legnica, Poland

Location

Uniw. Szpital Kliniczny im. N.Barlickiego,Oddział Nefrologii, Pododdział Dializ

Lodz, Poland

Location

Stacja Dializ NZOZ Avitum w Miechowie

Miechów, Poland

Location

Szpital Kliniczny im. H. Święcickiego, Oddział Nefrologii, Pododdział Dializ

Poznan, Poland

Location

Radomski Szpital Specjalistyczny im. T. Chałubińskiego, Oddział Dializ

Radom, Poland

Location

Stacja Dializ NZOZ Diaverum w Tczewie

Tczew, Poland

Location

Stacja Dializ NZOZ Avitum w Zgierzu

Zgierz, Poland

Location

Related Publications (1)

• Rijnders B, DiSciullo GJ, Csiky B, Rutkowski B, Appelt K, Cheronis J, Aitchison R, Gordon G, Jadoul M, Fluck R. Locking Hemodialysis Catheters With Trimethoprim-Ethanol-Ca-EDTA to Prevent Bloodstream Infections: A Randomized, Evaluator-blinded Clinical Trial. Clin Infect Dis. 2019 Jun 18;69(1):130-136. doi: 10.1093/cid/ciy840.

  PMID: 30281074 DERIVED

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• John C Cheronis, MD PhD

  Great Lakes Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 20, 2013
• Study Start: July 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

HU (10); PL (11)