Nonintubated Acute Respiratory Distress Syndrome (ARDS)Phase 2/3NCT07086755
Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury
A Phase 2/3 study testing Vadadustat 900mg and Vadadustat 1200mg in people with Nonintubated Acute Respiratory Distress Syndrome (ARDS) and Pathogen-associated Lung Injury, run by Paul Potnuru at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonintubated Acute Respiratory Distress Syndrome (ARDS), Pathogen-associated Lung Injury
- What is being tested?
- Vadadustat 900mg and Vadadustat 1200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to 31 May 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Paul J. Potnuru, MD, 713-500-6271, Paul.Potnuru@uth.tmc.edu
Paul Potnuru, MD
About this study
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.
- Being tested
- Vadadustat 900mg, Vadadustat 1200mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vadadustat 900mgDrug
Participants will receive 900mg vadadustat (as oral tablets) daily 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 1200mgDrug
Participants will receive 1200mg vadadustat (as oral tablets) daily 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.
PlaceboDrug
Participants will matching placebo (as oral tablets) daily 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 group | Role | What they receive |
|---|---|---|
| Vadadustat 900mg | Experimental | Not described Receives: Drug: Vadadustat 900mg |
| Vadadustat 1200mg | Experimental | Not described Receives: Drug: Vadadustat 1200mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The primary outcome is a hierarchical composite endpoint with 3 components: Death (yes or no); Duration of mechanical ventilation (MV) or extracorporeal membrane oxygenation (ECMO) in days; and Duration of high-flow nasal oxygenation (HFNO) or noninvasive ventilation (NIV) in days. Data will be reported as a Win Ratio, which quantifies the relative benefit of treatment compared to control. The Win Ratio is calculated from all pairwise comparisons of each patient in the treatment group compared with each patient in the control group, using the following formula: Win Ratio = Number of Wins/Number of Losses. Number of Wins is defined as: The count of pairs where the treatment group patient has a better outcome than the control group patient. Number of Losses is defined as: The count of pairs where the control group patient has a better outcome than the treatment group patient.
Measured: from the time of enrollment to 28 days after enrollment
Secondary outcomes (3)
Number of deaths
Measured: from the time of enrollment to 28 days after enrollment
Duration of mechanical ventilation (MV) or extracorporeal membrane oxygenation (ECMO) in days
Measured: from the time of enrollment to 28 days after enrollment
Duration of high-flow nasal oxygenation (HFNO) or noninvasive ventilation (NIV) in days
Measured: from the time of enrollment to 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start23 Oct 2025
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonintubated Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Potnuru
- Sponsor type
- University, hospital or other
- Collaborators
- Akebia Therapeutics
- Responsible party
- Sponsor-investigator, Paul Potnuru, The University of Texas Health Science Center, Houston
- Investigators
- Paul Potnuru, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086755
- Sponsor's protocol ID
- HSC-MS-22-0260
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury
- ClinicalTrials.gov ID
- NCT07086755
- Acronym / sponsor ID
- HSC-MS-22-0260
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Paul PotnuruUniversity, hospital or other
- Collaborators
- Akebia Therapeutics
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vadadustat 900mg | Experimental | Drug: Vadadustat 900mg |
| Vadadustat 1200mg | Experimental | Drug: Vadadustat 1200mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vadadustat 900mgParticipants will receive 900mg vadadustat (as oral tablets) daily 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. | Drug | Vadadustat 900mg |
| Vadadustat 1200mgParticipants will receive 1200mg vadadustat (as oral tablets) daily 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. | Drug | Vadadustat 1200mg |
| PlaceboParticipants will matching placebo (as oral tablets) daily 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. | Drug | Placebo |
Primary outcome
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
The primary outcome is a hierarchical composite endpoint with 3 components: Death (yes or no); Duration of mechanical ventilation (MV) or extracorporeal membrane oxygenation (ECMO) in days; and Duration of high-flow nasal oxygenation (HFNO) or noninvasive ventilation (NIV) in days. Data will be reported as a Win Ratio, which quantifies the relative benefit of treatment compared to control. The Win Ratio is calculated from all pairwise comparisons of each patient in the treatment group compared with each patient in the control group, using the following formula: Win Ratio = Number of Wins/Number of Losses. Number of Wins is defined as: The count of pairs where the treatment group patient has a better outcome than the control group patient. Number of Losses is defined as: The count of pairs where the control group patient has a better outcome than the treatment group patient.
3 secondary outcomes
Number of deaths
Time frame: from the time of enrollment to 28 days after enrollment
Duration of mechanical ventilation (MV) or extracorporeal membrane oxygenation (ECMO) in days
Time frame: from the time of enrollment to 28 days after enrollment
Duration of high-flow nasal oxygenation (HFNO) or noninvasive ventilation (NIV) in days
Time frame: from the time of enrollment to 28 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Potnuru, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vadadustat 900mg and Vadadustat 1200mg in people with Nonintubated Acute Respiratory Distress Syndrome (ARDS) and Pathogen-associated Lung Injury, run by Paul Potnuru at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Potnuru, MD (713-500-6271, Paul.Potnuru@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.