NCT07086755 Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury
| NCT ID | NCT07086755 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Bentley J. Bobrow |
| Condition | Nonintubated Acute Respiratory Distress Syndrome (ARDS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,100 participants in total. It began in 2025-10-23 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 * Placed on mechanical ventilation before randomization * Patients on home oxygen therapy * Time since hospital admission order placed \>72 hours * 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
Contact & Investigator
Paul Potnuru, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT07086755 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nonintubated Acute Respiratory Distress Syndrome (ARDS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07086755 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07086755 currently recruiting?
Yes, NCT07086755 is actively recruiting participants. Contact the research team at Paul.Potnuru@uth.tmc.edu for enrollment information.
Where is the NCT07086755 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07086755 clinical trial?
NCT07086755 is sponsored by Bentley J. Bobrow. The principal investigator is Paul Potnuru, MD at The University of Texas Health Science Center, Houston. The trial plans to enroll 1,100 participants.