Dialysis Catheter InfectionsPhase 3NCT01989091
Efficacy Study to Evaluate B-Lock™ as an Antimicrobial Lock Solution in Dialysis Patients With a CVC
A Phase 3 study testing B-Lock and Heparin 5,000 U/mL in people with Dialysis Catheter Infections, run by Great Lakes Pharmaceuticals Inc. at 21 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dialysis Catheter Infections
- What is being tested?
- B-Lock and Heparin 5,000 U/mL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Jul 2012to Oct 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.)
- 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.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
Poland11 sites
Stacja Dializ w NZOZ Centrum Chorób Wewnętrzynych "EL-VITA" w Elblągu
Elblag
Niepubliczny Zakład Opieki Zdrowotnej Diaverum Gdańsk Kartuska, Stacja Dializ
Gdansk
Stacja Dializ NZOZ Diaverum
Gdansk
Uniwersyteckie Centrum Kliniczne, Klinika Nefrologii, Transplantologii i Chorób Wewn
Gdansk
Stacja Dializ NZOZ Avitum w Legnicy
Legnica
Uniw. Szpital Kliniczny im. N.Barlickiego,Oddział Nefrologii, Pododdział Dializ
Lodz
Stacja Dializ NZOZ Avitum w Miechowie
Miechów
Szpital Kliniczny im. H. Święcickiego, Oddział Nefrologii, Pododdział Dializ
Poznan
Radomski Szpital Specjalistyczny im. T. Chałubińskiego, Oddział Dializ
Radom
Stacja Dializ NZOZ Diaverum w Tczewie
Tczew
Stacja Dializ NZOZ Avitum w Zgierzu
Zgierz
Hungary10 sites
FMC Dialízis Központ Péterfy S. Kórház
Budapest
FMC Dialízis Központ Szent István Kórház
Budapest
FMC Szépvölgyi Dialízis Központ
Budapest
DE OEC Nephrologiai Tanszék
Debrecen
FMC Dialízis Központ Eger
Eger
FMC Dialízis Központ Kecskemét
Kecskémet
FMC Nefrológiai Központ Miskolc
Miskolc
FMC Dialízis Központ Pécs
Pécs
FMC Szatellita Dialízis Központ Pécs
Pécs
Szegedi Tudományegyetem
Szeged
About this study
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
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.
Read more
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
- Being tested
- B-Lock, Heparin 5,000 U/mL
- Keywords
- kidney dialysis, hemodialysis, locking solution, antimicrobial, thrombolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-LockDevice
Also called IMD
Antimicrobial Catheter Lock Solution
Heparin 5,000 U/mLDrug
Also called ACH
Standard of Care Catheter Lock Solution
| Study group | Role | What they receive |
|---|---|---|
| B-Lock (IMD) | Experimental | Investigational Medical Device (IMD) Receives: Device: B-Lock |
| Heparin 5,000 U/mL (ACH) | Active comparator | Active Comparator Heparin (ACH) Receives: Drug: Heparin 5,000 U/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of adverse events (AEs), serious adverse events (SAEs) and device deficiencies (DDs) in the experimental and control populations
Measured: 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.
Measured: 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.
Measured: 39 weeks
Secondary outcomes (5)
The number of Lock Solution Failures in the experimental and control populations.
"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).
Measured: 39 weeks
The number of Occlusive Malfunction events in the experimental and control populations.
Measured: 39 weeks
The number of lock solution aspirate cultures that are positive for bacterial or fungal growth in the experimental and control populations.
Measured: 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).
Measured: 39 weeks
Catheter blood flow rates measured under standardized conditions over the duration of the study in the experimental and control populations.
Measured: 39 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startJul 2012
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Did not meet predetermined primary endpoint
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 Dialysis Catheter InfectionsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John C Cheronis, MD PhD, Study director, Great Lakes Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989091
- Sponsor's protocol ID
- GL-CL-0001
- Status last verified
- Feb 2017
- First submitted
- 30 Oct 2013
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30281074
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01989091
- Acronym / sponsor ID
- GL-CL-0001
- Conditions
- Dialysis Catheter Infections
- Keywords
- kidney dialysis, hemodialysis, locking solution, antimicrobial, thrombolytic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not meet predetermined primary endpoint
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Great Lakes Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Nov 2013 (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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-Lock (IMD) | Experimental | Device: B-LockInvestigational Medical Device (IMD) |
| Heparin 5,000 U/mL (ACH) | Active comparator | Drug: Heparin 5,000 U/mLActive Comparator Heparin (ACH) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| B-LockAlso: IMDAntimicrobial Catheter Lock Solution | Device | B-Lock (IMD) |
| Heparin 5,000 U/mLAlso: ACHStandard of Care Catheter Lock Solution | Drug | Heparin 5,000 U/mL (ACH) |
Primary outcome
The number of adverse events (AEs), serious adverse events (SAEs) and device deficiencies (DDs) in the experimental and control populations
Time frame: 39 weeks
The number of thrombolytic treatment events in the experimental and control populations.
Time frame: 39 weeks
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
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.
5 secondary outcomes
The number of Lock Solution Failures in the experimental and control populations.
Time frame: 39 weeks
The number of Occlusive Malfunction events in the experimental and control populations.
Time frame: 39 weeks
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
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
Catheter blood flow rates measured under standardized conditions over the duration of the study in the experimental and control populations.
Time frame: 39 weeks
Results and safety
The study was stopped early (reason given: Did not meet predetermined primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Derived from this study: PubMed 30281074Rijnders 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.
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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.
John C Cheronis, MD PhD study director
Great Lakes Pharmaceuticals Inc.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing B-Lock and Heparin 5,000 U/mL in people with Dialysis Catheter Infections, run by Great Lakes Pharmaceuticals Inc. at 21 sites in 2 countries.
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 6 inclusion and 17 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: stopped early, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Poland, Hungary. 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?
The study was stopped early (reason given: Did not meet predetermined primary endpoint). 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?
The number of adverse events (AEs), serious adverse events (SAEs) and device deficiencies (DDs) in the experimental and control populations (time frame: 39 weeks). The study lists 3 primary outcomes in all. 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 NCT01989091, 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 27 Feb 2017.