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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Nonintubated Acute Respiratory Distress Syndrome (ARDS), Pathogen-associated Lung Injury

In brief

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 facts

Study ID: NCT07086755
Run by: Paul Potnuru
People needed: 1100
Starts: 2025-10-23
Expected to finish: 2031-05-31
Last updated by the study team: 2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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