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
Last Update Posted : August 14, 2020
|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
- Occurrence of catheter related bloodstream infection [ Time Frame: 18 months (data will be collected at the time event occurs) ]
- 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.
- 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 ]
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|