The VSTAT-2 Trial: A Phase IIb/III Trial of Vadadustat for Nonintubated ARDS

Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury (VSTAT-2 Trial) | ClinicalTrials.gov NCT07086755

Acute respiratory distress syndrome (ARDS) remains one of the most serious and resource-intensive conditions managed in the intensive care unit, carrying significant morbidity and mortality despite decades of supportive care advances. For patients who develop ARDS in the setting of active infection and are managed without mechanical ventilation, effective pharmacologic options remain limited.

The VSTAT-2 Trial is an ongoing adaptive seamless Phase IIb/III randomized controlled trial evaluating vadadustat, an FDA-approved oral hypoxia-inducible factor prolyl hydroxylase inhibitor, as a potential treatment for pathogen-associated nonintubated ARDS. The trial builds on VSTAT-1, a completed Phase II study (n=448) whose results were published in JCI Insight in 2025, and is designed to enroll up to 1,100 participants across multiple sites in the Texas Medical Center and greater Houston area.