BOSTON — Neutrolin, an investigational new drug containing taurolidine, was shown to reduce catheter-related bloodstream infections among patients with ESRD who were on hemodialysis via a central venous catheter, according to data presented at the National Kidney Foundation Spring Clinical Meetings.
“LOCK-IT-100 is a landmark study – the largest randomized centralized study of a catheter-lock solution that is Neutrolin – in ESRD subjects who are using a catheter for hemodialysis. In this study, Neutrolin catheter-lock solution significantly reduced catheter-related bloodstream infections, which are a leading cause of mortality in hemodialysis,” Anil Agarwal, MD, FNKF, said during his presentation here.
Agarwal, of The Ohio State University College of Medicine in Columbus, Ohio, presented phase 3 results of LOCK-IT 100, a prospective, multicenter, double-blind, randomized, active control study. Agarwal and colleagues compared the safety and effectiveness of Neutrolin (CRMD003, CorMedix Inc.) for patients with ESRD who were on hemodialysis and used tunneled dialysis catheter (TDC) in a 1:1 ratio to patients who received heparin (1,000 U/mL) to reduce catheter-related bloodstream infection (CRBSI).
Researchers enrolled 805 patients from 70 sites in the United States. The primary endpoint was the risk of CRBSI. Secondary endpoints were catheter removal for any reason and loss of TDC patency, which was defined as recombinant tissue plasminogen activator administration or catheter removal due to malfunction. Agarwal said a planned interim analysis on the first 28 cases was terminated at the recommendation of the Data and Safety Monitoring Board based on an observed 72% reduction in the risk of CRBSI by Neutrolin compared to heparin.
The final analysis included 795 patients – 397 patients in the Neutrolin group and 398 patients in the heparin group. Researchers found nine CRBSIs for patients in the Neutrolin group compared with 32 CRBSIs for patients in the heparin group – a 71% reduction in CRBSIs. The rates of treatment-emergent serious adverse events were 5.1 per patient for Neutrolin and 5.8 per patient for heparin. Researchers found secondary endpoints showed no statically significant difference.
“As compared to heparin, there was no significant difference in secondary outcomes of catheter removals for any reason or loss of catheter patency,” he said.
Agarwal said the FDA awarded Neutrolin fast-track status and qualified infectious disease product designation. The company is working with the FDA to obtain approval for commercial distribution in the United States. It is currently CE marked as a class III medical device for multiple indications. ꟷ by Kristine Houck, MA, ELS
Agarwal A, et al. Poster 441. Presented at: National Kidney Foundation Spring Clinical Meetings; May 8-12, 2019; Boston.
Disclosure: Agarwal reports he is a consultant for CorMedix Inc. The LOCK-IT-100 study was sponsored by CorMedix Inc.