Humacyte completes enrollment in Phase III of Humacyl for ESRD

Humacyte Inc. (Research Triangle Park, N.C.) completed enrollment of 350 evaluable patients with end-stage renal disease (ESRD) in the Phase III HUMANITY trial evaluating Humacyl (HumaGraft, Human Acellular Vascular Graft (HAVG), Tissue-engineered vascular grafts (TEVGs)). The open-label, international trial is comparing Humacyl to expanded polytetrafluoroethylene (ePTFE) grafts as conduits for hemodialysis in patients who require renal replacement therapy and are not candidates for fistula. Humacyte expects data from the trial late next year.

The trial’s primary endpoint is time to loss of secondary patency. Secondary endpoints include time to loss of primary patency, efficacy of dialysis and safety...