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Kidney Failure, ChronicPhase 3NCT02651428

Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection

A Phase 3 study testing Neutrolin and Heparin in people with Kidney Failure, Chronic and Catheter-Related Infections, run by CorMedix Therapeutics at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Neutrolin and Heparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
806 participants
Where
5 sitesUnited States
Study dates
Dec 2015to Oct 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Subject has ESRD and undergoes chronic HD at least two times per week
  • Subject has a HD catheter that has demonstrated the ability to achieve a minimum blood flow of at least 250 mL/min for at least two consecutive dialysis sessions blood flow to enable successful HD
  • The HD catheter is implanted with the tip in a jugular or subclavian vein
  • The subject is not expected to expire within 180 days
  • The subject is likely to require the use of a CVC for at least 90 days
  • The subject (or the legal guardian) understands the nature of the study and provides written informed consent prior to the study enrollment
  • The subject is willing to comply with specified follow-up evaluations and prescribed dialysis therapy and
  • If female and of childbearing potential, the subject must have a negative pregnancy test at the screening visit (i.e., subject is not pregnant); not be lactating; and use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or hormonal contraceptive (oral, implant, ring, patch) for the duration of the study. (NOTE: The subject must have used the chosen method of birth control for at least 1 month/cycle prior to enrollment into the study).

Who cannot join

  • Subjects who received antibiotics within the last 14 days
  • Visible evidence of compromised skin integrity is present at the catheter exit site or evidence of a catheter exit site infection
  • Subject has received any thrombolytic treatment (i.e., tPA) in their current catheter within 30 days of randomization
  • Fill volume of HD catheter is unknown or cannot be determined
  • Subjects using any type of antimicrobial-coated or heparin-coated catheter
  • Documented chronic bleeding diathesis, active or recurrent bleeding within 1 month prior to randomization
Show all 18Show fewer
  • Documented history of an atrial thrombus or known hypercoagulable state
  • Subjects with open, non-healing skin ulcers
  • Current requirement for systemic immunosuppression that would increase risk of infection
  • Active malignancy requiring or anticipated to require chemotherapy likely to cause leukopenia and/or immunosuppression
  • Known allergy or absolute contraindication to citrate, taurolidine or heparin or a history of heparin-induced thrombocytopenia
  • Unstable malignancy
  • Cirrhosis with encephalopathy
  • Subject is currently taking another medication with known systemic drug interaction with citrate, taurolidine, or heparin
  • Subject is currently enrolled in another investigational device and/or drug trial or has participated in another investigational device and/or drug trial within 30 days prior to enrollment
  • Subject is anticipated to receive a renal transplant within 90 days (subjects can be on the transplant list, but a subject with a known or anticipated transplant date within the next 90 days should be excluded)
  • Any other medical condition which renders the subject unable to or unlikely to complete the study, or which would interfere with optimal participation in the study or produce significant risk to the subject.
  • -

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Diagnostic Clinic of Houston

    Houston, Texas, 77004

  • North Beach Dialysis Center Inc.

    Miami Gardens, Florida, 33169

  • Lower Manhattan Dialysis Center

    New York, New York, 10016

  • Riverside Nephrology Physicians/Van Buren Dialysis center

    Riverside, California, 92503

  • North America Research Institute

    San Dimas, California, 91773

Other trials in United States

About this study

Official title: Phase 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness of Neutrolin in Preventing Catheter-related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease

The purpose of this study is determine safety and effectiveness of Neutrolin, a catheter lock solution, for prevention of central venous catheter associated bloodstream infection in hemodialysis patients.

Read the detailed description

The objective of this study is to demonstrate the efficacy and safety of Neutrolin® as a catheter lock solution (CLS) on prevention of catheter-related bloodstream infection (CRBSI), and the incidence of treatment-emergent adverse events in subjects receiving hemodialysis (HD) for the treatment of End Stage Renal Disease (ESRD) when compared with heparin 4,000 USP Units/4mL (1,000 USP Units/mL).

This is a randomized, double-blind, active control, parallel-arm, multicenter study. Six hundred and thirty two subjects will be randomized in a 1:1 ratio to receive either Neutrolin® or the active control heparin (Heparin sodium USP 1,000 units/mL, Benzyl alcohol 9.45 mg/mL and Sodium chloride 9.0 mg/mL) as a CLS.

Approximately 632 randomized subjects are planned for this trial. In this study, one-half of the subjects (316 subjects) will receive Neutrolin as a study drug and the other half will receive heparin 4,000 USP Units/4mL (1,000 USP Units/mL) with benzyl alcohol preservative as a comparator. Subjects will be assigned in a 1:1 ratio using permuted blocks without additional stratification for both groups.

The primary objective of this study is to demonstrate the effectiveness of Neutrolin® as a CLS in ESRD subjects undergoing HD treatment using a permanent, cuffed, tunneled silicone or polyurethane HD catheter. The study will evaluate whether Neutrolin® is superior to the active control heparin by documenting the time to CRBSI and consequently delaying the time until the occurrence of CRBSI.

Being tested
Neutrolin, Heparin
Keywords
Kidney Failure, Chronic, Catheter-Related Infections, Central Venous Catheter
Medical subject headings
Kidney Failure, Chronic, Catheter-Related Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeutrolinDrug

    Also called 1.35% taurolidine, 3.5% citrate, heparin 1,000 USP Units/mL

    Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session

  • HeparinDrug

    Also called Heparin Sodium

    Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session

Study groups in NCT02651428
Study groupRoleWhat they receive
Neutrolin armExperimentalNeutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution
Receives: Drug: Neutrolin
Heparin armActive comparatorHeparin: Heparin will be added to the central venous catheter after dialysis as a lock solution
Receives: Drug: Heparin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of a CAC-Adjudicated Catheter-Related Bloodstream Infection (CRBSI) in Subjects Receiving Hemodialysis for the Treatment of End Stage Renal Disease (ESRD): Final Analysis

    CRBSI was defined as the same organism grown from at least one positive blood culture from a peripheral site or bloodline sample, or either the arterial or venous catheter hub. The final assessment of CRBSI was determined by a Clinical Adjudication Committee (CAC) who used both clinical documentation and blood culture results in their assessment.

    Measured: The event time was the number of days from randomization until the occurrence of a CAC-Adjudicated CRBSI or until the subject was censored. The mean participant duration of exposure to study drug was 174 days (range 4-884 days).

Secondary outcomes (1)

  1. Participants With a Study Catheter Removal for Any Reason

    Analysis of all catheter removals during the study or until the catheter was removed

    Measured: The event time was the number of days from randomization until catheter removal for any reason or until the subject was censored. The mean participant duration of exposure to study drug was 174 days (range 4-884 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionOct 2018
  4. Study completionOct 2018

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02651428
Sponsor's protocol ID
LOCK-IT-100
Status last verified
Feb 2025
First submitted
7 Jan 2016
Last updated
25 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Agarwal AK, Crandon J, Hurlburt E, Michaud M, Pfaffle A, Roy-Chaudhury P, Medina C, Conway PT, Hickey EV 3rd. A plain language summary of the LOCK IT-100 study of taurolidine/heparin catheter lock solution and catheter-related bloodstream infection in hemodialysis. Future Microbiol. 2025 Sep;20(13):855-872. doi: 10.1080/17460913.2025.2547498. Epub 2025 Sep 2.

    PubMed 40891537

  • Agarwal AK, Roy-Chaudhury P, Mounts P, Hurlburt E, Pfaffle A, Poggio EC. Taurolidine/Heparin Lock Solution and Catheter-Related Bloodstream Infection in Hemodialysis: A Randomized, Double-Blind, Active-Control, Phase 3 Study. Clin J Am Soc Nephrol. 2023 Nov 1;18(11):1446-1455. doi: 10.2215/CJN.0000000000000278. Epub 2023 Sep 6.

    PubMed 37678222

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neutrolin and Heparin in people with Kidney Failure, Chronic and Catheter-Related Infections, run by CorMedix Therapeutics at 5 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 8 inclusion and 18 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: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Yes. Results are posted in the registry (first posted 31 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Presence of a CAC-Adjudicated Catheter-Related Bloodstream Infection (CRBSI) in Subjects Receiving Hemodialysis for the Treatment of End Stage Renal Disease (ESRD): Final Analysis (time frame: The event time was the number of days from randomization until the occurrence of a CAC-Adjudicated CRBSI or until the subject was censored. The mean participant duration of exposure to study drug was 174 days (range 4-884 days).). 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 NCT02651428, which also lists 2 linked publications.

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 25 Feb 2025.

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