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

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ClinicalTrials.gov Identifier: NCT02651428
Recruitment Status : Recruiting
First Posted : January 11, 2016
Last Update Posted : February 9, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Catheter-Related Infections Drug: Neutrolin Drug: Heparin Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 632 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : December 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Neutrolin arm
Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution
Drug: Neutrolin
Neutrolin® or 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
Other Name: 1.35% taurolidine, 3.5% citrate, heparin 1,000 USP Units/mL
Active Comparator: Heparin arm
Heparin: Heparin will be added to the central venous catheter after dialysis as a lock solution
Drug: Heparin
Neutrolin® or 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
Other Name: Heparin Sodium

Outcome Measures

Primary Outcome Measures :
  1. Occurrence of catheter related bloodstream infection [ Time Frame: 18 months (data will be collected at the time event occurs) ]

Secondary Outcome Measures :
  1. Catheter Patency: Loss of catheter patency following enrollment in the study. Catheter Removal: Catheter removal for any reason. [ Time Frame: 18 months ]
    Loss of catheter patency is defined as required use of a tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction.

Other Outcome Measures:
  1. Biofilm Analysis: The analysis will aim to determine if endoluminal bacterial colonization is present, identify the species and quantify the thickness of the biofilm. [ Time Frame: 18 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject has ESRD and undergoes chronic HD at least two times per week
  2. 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
  3. The HD catheter is implanted with the tip in a jugular or subclavian vein
  4. The subject is not expected to expire within 180 days
  5. The subject is likely to require the use of a CVC for at least 90 days
  6. The subject (or the legal guardian) understands the nature of the study and provides written informed consent prior to the study enrollment
  7. The subject is willing to comply with specified follow-up evaluations and prescribed dialysis therapy and
  8. 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).

Exclusion Criteria:

  1. Subjects who received antibiotics within the last 14 days
  2. Visible evidence of compromised skin integrity is present at the catheter exit site or evidence of a catheter exit site infection
  3. Subject has received any thrombolytic treatment (i.e., tPA) in their current catheter within 30 days of randomization
  4. Fill volume of HD catheter is unknown or cannot be determined
  5. Subjects using any type of antimicrobial-coated or heparin-coated catheter
  6. Documented chronic bleeding diathesis, active or recurrent bleeding within 1 month prior to randomization
  7. Documented history of an atrial thrombus or known hypercoagulable state
  8. Subjects with open, non-healing skin ulcers
  9. Current requirement for systemic immunosuppression that would increase risk of infection
  10. Active malignancy requiring or anticipated to require chemotherapy likely to cause leukopenia and/or immunosuppression
  11. Known allergy or absolute contraindication to citrate, taurolidine or heparin or a history of heparin-induced thrombocytopenia
  12. Unstable malignancy
  13. Cirrhosis with encephalopathy
  14. Subject is currently taking another medication with known systemic drug interaction with citrate, taurolidine, or heparin
  15. 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
  16. 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)
  17. 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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651428

Contact: Janine Ritchie 512-913-5160 Janine.ritchie@ppdi.com
Contact: Daniela Sinisi +54114310-7811 Daniela.sinisi@ppdi.com

United States, California
Riverside Nephrology Physicians/Van Buren Dialysis center Recruiting
Riverside, California, United States, 92503
Contact: Mohammed Khan, MD         
North America Research Institute Recruiting
San Dimas, California, United States, 91773
Contact: Aamir Jamal, MD         
North America Research Institute Recruiting
San Dimas, California, United States, 91773
Contact: Michael Bien, MD         
United States, Florida
North Beach Dialysis Center Inc. Recruiting
Miami Gardens, Florida, United States, 33169
Contact: Fabiola Schlessinger, MD         
United States, New York
Lower Manhattan Dialysis Center Recruiting
New York, New York, United States, 10016
Contact: Albert Matalon, MD         
United States, Texas
Diagnostic Clinic of Houston Recruiting
Houston, Texas, United States, 77004
Contact: Freemu Varghese, MD         
Sponsors and Collaborators
JMI Laboratories
Spectra Clinical Research
Davita Clinical Research
Frenova Renal Research
Study Director: Antony Pfaffle, MD Chief Scientific Officer
More Information

Responsible Party: CorMedix
ClinicalTrials.gov Identifier: NCT02651428     History of Changes
Other Study ID Numbers: LOCK-IT-100
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by CorMedix:
Kidney Failure, Chronic
Catheter-Related Infections
Central Venous Catheter

Additional relevant MeSH terms:
Communicable Diseases
Renal Insufficiency
Kidney Failure, Chronic
Catheter-Related Infections
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action