Talphera announced that the company expects to initiate the registrational study of Niyad?, the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) Study, shortly. The study has already received central Institutional Review Board (IRB) approval. The study is designed as a prospective, double-blinded trial to be conducted at up to 10 U.S. hospital intensive care units.

The study will enroll and evaluate 166 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints 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.

The first patient is expected to be enrolled for the NEPHRO study in the first quarter of 2024. Since the end of last year, the company has completed all sponsor actions and is awaiting activation from registered sites. A PMA submission for Niyad is expected to be filed with the FDA in the second half of 2024.