California-based specialty pharmaceutical company Talphera, Inc. (Nasdaq: TLPH) announced on Monday that it has enrolled its first subject in the NEPHRO CRRT study.

The NEPHRO CRRT registrational study is to enrol 166 subjects undergoing continuous renal replacement therapy (CRRT) at up to 14 clinical sites across the United States.

The study's primary endpoint is the mean post-filtre activated clotting time for circuits infused with nafamostat compared to placebo over the first 24 hours.

Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities while Niyad is a lyophilised formulation of nafamostat. Presently, Niyad is being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the US FDA.