Core Insights - Talphera, Inc. has initiated the NEPHRO CRRT registrational trial to assess the safety and effectiveness of nafamostat in 166 patients across up to 14 clinical sites in the U.S. [1][2] - The primary endpoint of the NEPHRO CRRT study is the mean post-filter activated clotting time for circuits infused with nafamostat compared to placebo over the first 24 hours [2][7] - Nafamostat has been a standard of care in Japan and South Korea for over 30 years, and its approval in the U.S. could enhance anticoagulant options for patients requiring continuous renal replacement therapy (CRRT) [3][4] Company Overview - Talphera, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for medically supervised settings [5] - The company's lead product candidate, Niyad™, is a lyophilized formulation of nafamostat, currently studied under an investigational device exemption (IDE) and has received Breakthrough Device Designation from the FDA [5][4] Study Details - The NEPHRO CRRT study is a prospective, double-blinded trial designed to enroll 166 adult patients who cannot tolerate heparin or are at risk for bleeding [7] - Key secondary endpoints of the study include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours, and dialysis efficacy based on urea concentration over the first 24 hours [7]
Talphera Announces First Patient Enrolled in the Registrational Trial Evaluating Nafamostat for Anticoagulation of the Extracorporeal Circuit