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

NCT02651428 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: LOCK-IT-100
• Study Type: interventional
• Target: 806
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Kidney Failure, Chronic; Catheter-Related Infections

Keywords

Kidney Failure, Chronic; Catheter-Related Infections; Central Venous Catheter

Outcome Measures

Primary Outcomes (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.

  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)

• Participants With a Study Catheter Removal for Any Reason

  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).

Study Arms (2)

Neutrolin arm

EXPERIMENTAL

Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution

Drug: Neutrolin

Heparin arm

ACTIVE COMPARATOR

Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution

Drug: Heparin

Interventions

Neutrolin DRUG

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will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session

Also known as: 1.35% taurolidine, 3.5% citrate, heparin 1,000 USP Units/mL

Neutrolin arm

Heparin DRUG

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

Also known as: Heparin Sodium

Heparin arm

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• CorMedix: lead
• PPD Development, LP: collaborator
• JMI Laboratories: collaborator
• Spectra Clinical Research: collaborator
• Davita Clinical Research: collaborator
• Frenova Renal Research: collaborator

Study Sites (5)

Riverside Nephrology Physicians/Van Buren Dialysis center

Riverside, California, 92503, United States

Location

North America Research Institute

San Dimas, California, 91773, United States

Location

North Beach Dialysis Center Inc.

Miami Gardens, Florida, 33169, United States

Location

Lower Manhattan Dialysis Center

New York, New York, 10016, United States

Location

Diagnostic Clinic of Houston

Houston, Texas, 77004, United States

Location

Related Publications (2)

• 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.

  PMID: 40891537 DERIVED

• 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.

  PMID: 37678222 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Catheter-Related Infections

Interventions

taurolidine; Citric Acid; Heparin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: CorMedix Inc.

lmasson@cormedix.com

908-517-9500

Study Officials

• Antony Pfaffle, MD

  Chief Scientific Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 11, 2016
• Study Start: December 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 25, 2025
• Results First Posted: August 31, 2021

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)