Could a pill help patients breathe easier with ARDS?
NCT ID NCT07086755
First seen Jun 24, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This study tests a drug called vadadustat in 1,100 hospitalized adults with acute respiratory distress syndrome (ARDS) caused by infection. Participants take either a low or high dose of vadadustat or a placebo daily for up to 14 days. The goal is to see if the drug reduces deaths and the need for breathing support like ventilators.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vadadustat (oral tablet)
- What this could lead to
- If it works, this could provide a new treatment to reduce deaths and shorten the need for breathing machines in patients with severe lung injury.
- What could go wrong
- This is an early-to-mid stage trial, so results may not confirm benefit. The drug may cause side effects or not improve outcomes compared to placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 1,100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: -Meets the definition of nonintubated ARDS per the 2024 Global Definition of ARDS that includes all the following (2A-2D): * 2A. Risk factors and origin of pulmonary edema: Precipitated by an acute predisposing risk factor, specifically from a suspected pathogen-associated etiology such as pneumonia\* or non-pulmonary infection\*\* \[\*Pneumonia defined as known or suspected based on treating physician documentation or discussion, OR both of the following criteria: 1) Chest radiography with new infiltrates, consolidation, or cavitation and (2) Clinical signs of pneumonia (new cough, sputum, fever, or white blood cells (WBC) \> 12,000)\] \[\*\*Non-pulmonary infection defined as suspected or proven infection meeting any of the following criteria: treating clinician suspects a viral, bacterial, or fungal infection, or cultures ordered in the past 24h or positive cultures within 1 week; or orders for antimicrobial medication.\] * 2B. Oxygenation: PaO2:FIO2 ≤ 300 mm Hg or SpO2:FIO2 ≤ 315 (if SpO2 ≤ 97%) on High-Flow Nasal Oxygen (HFNO) with flow of ≥ 30 L/min or non-invasive ventilation (NIV)/continuous positive airway pressure (CPAP) with at least 5 cm H2O end-expiratory pressure * 2C. Timing: Acute onset or worsening of hypoxemic respiratory failure within 1 week of the estimated onset of the predisposing risk factor or new or worsening respiratory symptoms. * 2D. Chest imaging: Chest infiltrates on radiography and computed tomography or B lines and/or consolidations on ultrasound not fully explained by effusions, atelectasis, or nodules/masses. Exclusion Criteria: * Hypersensitivity to vadadustat or any of its excipients * Hemoglobin above the gender-specific upper limit of normal (ULN) at randomization: 16 grams/deciliter (g/dL) for females and 18 g/dL for males * Patients with Aspartate transferase (AST) or Alanine aminotransferase (ALT) levels \>5 times the upper limit of normal * Patients with AST or ALT levels \>3 times the upper limit of normal along with a total bilirubin elevation of \>2 times the upper limit of normal. * Patients who have erythrocytosis or polycythemia vera * Patients with uncontrolled hypertension * Patients with active malignancy * Patients with liver cirrhosis or active, acute liver disease * Patients taking erythropoiesis-stimulating agents * Patient taking probenecid, rifampicin, gemfibrozil, or teriflunomide * Women who are pregnant or breastfeeding, or positive pregnancy test before randomization * Patients who are prisoners * Patients who are currently enrolled in any other interventional clinical trial * Patients who have any prior history of arterial or venous thromboembolism within the past 3 months * Patients with a history of myocardial infarction, cerebrovascular event, or acute coronary syndrome within the past 3 months * Patients with known or suspected tuberculosis infection * Moribund patient not expected to survive 48 hours
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas Health Science Center at Houston
RECRUITINGHouston, Texas, 77030, United States