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

Conditions

• Nonintubated Acute Respiratory Distress Syndrome (ARDS)
• Pathogen-associated Lung Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vadadustat 900mg — DRUG
  Participants will receive 900mg vadadustat (as oral tablets) for 14 days or until the date of discharge, whichever comes first, at approximately the same time each day without regard for timing of meals.
• Vadadustat 1200mg — DRUG
  Participants will receive 1200mg vadadustat (as oral tablets) for 14 days or until the date of discharge, whichever comes first, at approximately the same time each day without regard for timing of meals.
• Placebo — DRUG
  Participants will matching placebo (as oral tablets) for 14 days or until the date of discharge, whichever comes first, at approximately the same time each day without regard for timing of meals.

Study Details

The objective of this study is to assess the efficacy and safety of vadadustat for treating hospitalized patients with nonintubated Acute Respiratory Distress Syndrome (ARDS) secondary to pathogen-associated lung injury.

Key Dates

Start date

Oct 23, 2025

Status verified

Dec 2025

Primary completion

Jul 1, 2026

Completion

Jul 1, 2026

Study Design

Enrollment

1,100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Vadadustat 900mg
• Experimental: Vadadustat 1200mg
• Placebo Comparator: Placebo

Primary Outcome Measure

Win ratio for hierarchical composite endpoint based on death, duration of mechanical ventilation or ECMO, and duration of high-flow nasal oxygenation or non-invasive ventilation [ Time Frame: from the time of enrollment to 28 days after enrollment ]

Central Contacts

• Paul Potnuru, MD
  713-500-6271
  [email protected]

Locations (1)

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