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 :
Completed
First Posted : January 11, 2016
Results First Posted : August 31, 2021
Last Update Posted : August 31, 2021
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Condition or disease | Intervention/treatment | Phase |
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Kidney Failure, Chronic Catheter-Related Infections | Drug: Neutrolin Drug: Heparin | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 806 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 |
Actual Primary Completion Date : | October 2018 |
Actual Study Completion Date : | October 2018 |
Arm | Intervention/treatment |
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Experimental: Neutrolin arm
Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution
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Drug: Neutrolin
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
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
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Drug: Heparin
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 |
- 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). ]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.
- Participants With a Study Catheter Removal for Any Reason [ Time Frame: 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). ]Analysis of all catheter removals during the study or until the catheter was removed
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
- 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)
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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.
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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
United States, California | |
Riverside Nephrology Physicians/Van Buren Dialysis center | |
Riverside, California, United States, 92503 | |
North America Research Institute | |
San Dimas, California, United States, 91773 | |
United States, Florida | |
North Beach Dialysis Center Inc. | |
Miami Gardens, Florida, United States, 33169 | |
United States, New York | |
Lower Manhattan Dialysis Center | |
New York, New York, United States, 10016 | |
United States, Texas | |
Diagnostic Clinic of Houston | |
Houston, Texas, United States, 77004 |
Study Director: | Antony Pfaffle, MD | Chief Scientific Officer |
Documents provided by CorMedix:
Responsible Party: | CorMedix |
ClinicalTrials.gov Identifier: | NCT02651428 |
Other Study ID Numbers: |
LOCK-IT-100 |
First Posted: | January 11, 2016 Key Record Dates |
Results First Posted: | August 31, 2021 |
Last Update Posted: | August 31, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Kidney Failure, Chronic Catheter-Related Infections Central Venous Catheter |
Infections Communicable Diseases Sepsis Catheter-Related Infections Renal Insufficiency Kidney Failure, Chronic Disease Attributes Pathologic Processes Kidney Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases |
Systemic Inflammatory Response Syndrome Inflammation Renal Insufficiency, Chronic Chronic Disease Taurolidine Heparin Calcium heparin Anticoagulants Molecular Mechanisms of Pharmacological Action Fibrinolytic Agents Fibrin Modulating Agents Anti-Infective Agents Anti-Infective Agents, Local Antineoplastic Agents |