Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02651428|
Recruitment Status : Completed
First Posted : January 11, 2016
Results First Posted : August 31, 2021
Last Update Posted : August 31, 2021
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Experimental: Neutrolin arm
Neutrolin: Neutrolin will be added to the central venous catheter after dialysis as a lock solution
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
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
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|