CorMedix Inc. (NYSEAMERICAN:CRMD) reported that the Clinical Adjudication Committee established to independently and critically evaluate catheter-related bloodstream infections, has reviewed prospective cases of CRBSI in the firm’s LOCK-IT-100 trial of hemodialysis suffering people with central venous catheters that happened through December 2017, and recorded 28 such instances. As previously decided with FDA, an interim assessment will be done when the initial 28 CRBSIs case have been recorded. The main endpoint for the trial is the decline of CRBSI by Neutrolin versus a heparin catheter lock solution.
CorMedix is presently directing standard processes to ensure the completeness and accuracy of the data needed for performing the interim analysis. This assessment comprises data for all people in the study required to evaluate the two secondary endpoints linked to a decline in catheter blockage and catheter removal, as well as the main endpoint and safety data.
Before the full dataset can be protected and the interim assessment can proceed, several weeks will be needed to close the quality assurance processes appropriate for the sum of data generated in the study. The interim assessment will be offered to the Data Safety Monitoring Board for recommendation and review upon completion. The firm expects that DSMB assessment will occur in Q2 2018.
Khoso Baluch, the CEO of CorMedix, said that they are thrilled about the progress they are making and look forward to offering further updates as they achieve the objectives discussed above. LOCK-IT-100 Trial marks as a multi-center Phase III clinical study in hemodialysis suffering people with central venous catheters in the United States.
It is a prospective, double-blind, randomized, active control study intended to demonstrate the safety and efficacy of Neutrolin in preventing CRBSI in subjects getting hemodialysis therapy as cure for last stage renal disease. The study will assess whether Neutrolin is better than the active control heparin by recording the incidence of catheter-related bloodstream infections and the time until the incidence of CRBSI as the main endpoint.