OCE-205, a selective V1a receptor mixed agonist–antagonist, for the treatment of hepatorenal syndrome–acute kidney injury: A phase 2 randomized trial

BACKGROUND AND AIMS: OCE-205 is a mixed agonist-antagonist selective for the vasopressin 1a (V1a) receptor with no vasopressin 2 (V2) receptor activity. Safety and efficacy of OCE-205 were evaluated in patients with hepatorenal syndrome-acute kidney injury (HRS-AKI). APPROACH AND RESULTS: A randomized, double-blind, placebo-controlled, dose-ranging study was conducted at 23 North American centers. Patients received a continuous infusion of OCE-205 at 8, 15, 30, or 50 µg/h or placebo. The primary endpoint was time to confirmed clinical improvement, defined as serum creatinine (sCr)