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, 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 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 as the primary endpoint. 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.
Current Status: LOCK-IT-100 is an event-driven study and study completion is dependent upon capturing 56 total CRBSI events. An interim efficacy analysis is expected to occur in the fourth quarter 2017, followed by enrollment completion in the second quarter 2018. The study is expected to conclude around year end 2018.
CorMedix is assessing the structure of its second planned Phase 3 study to seek possible efficiencies and improvements in its design and execution.