CorMedix is currently enrolling a multi-center Phase 3 clinical trial in hemodialysis patients with central venous catheters in the U.S. named Catheter Lock Solution Investigational Trial, or LOCK-IT-100. It is a prospective, randomized, double-blind, placebo-controlled, active control trial designed to demonstrate the efficacy and safety of Neutrolin for preventing catheter-related bloodstream infections, or CRBSI, in subjects receiving hemodialysis therapy as treatment for end stage renal disease. The primary endpoint for the trial is freedom from CRBSI. The trial will evaluate whether Neutrolin is superior to the active control heparin by documenting the incidence of CRBSI and the time until the occurrence of CRBSI. Key secondary endpoints are catheter patency, which is defined as required use of tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction and catheter removal for any reason. An exploratory endpoint of biofilm analysis will be evaluated in the first 200 catheters removed.
Current Status: LOCK-IT-100 is an event-driven study that will enroll approximately 630 patients. Enrollment is expected to be completed by year-end 2017 and final results from the study are expected in the second half of 2018.
For more information on the trial, visit: https://clinicaltrials.gov/ct2/show/NCT02651428?term=neutrolin&rank=1.
CorMedix is planning to initiate a second Phase 3 study in oncology/TPN (total parenteral nutrition) patients.