Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury

◇ Purpose of the Study

The VSTAT-2 Trial is designed to determine whether vadadustat can improve outcomes in patients experiencing serious, infection-driven breathing failure.

01 Trial at a Glance

Design Phase IIb / III adaptive seamless RCT Randomized · controlled · adaptive dose selection

Investigational Drug Vadadustat Oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)

Population Adults with pathogen-associated nonintubated ARDS Hospitalized patients with acute lung injury causing hypoxia requiring high levels of oxygen support with non-invasive ventilation or high-flow nasal oxygenation

Builds On VSTAT-1 (Phase 2) Completed predecessor study published in JCI Insight, 2025

02 Protocol Summary

VSTAT-2 is a Phase IIb/III adaptive seamless randomized controlled trial evaluating vadadustat — an FDA-approved oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) — in adults hospitalized with pathogen-associated nonintubated acute respiratory distress syndrome (ARDS).

The trial builds on the completed Phase 2 VSTAT-1 study, published in JCI Insight in 2025, which evaluated vadadustat in a similar patient population with viral pneumonia.

03 Eligibility & Locations

Basic Eligibility

Adults hospitalized with pathogen-associated nonintubated ARDS.

Full inclusion and exclusion criteria are available from the study team. Eligibility is determined by the treating clinical and research teams in accordance with the trial protocol.

Study Sites

Houston, Texas.

For a current list of participating sites, please contact the trial team.