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

NCT07086755 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HSC-MS-22-0260
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  from the time of enrollment to 28 days after enrollment

Secondary Outcomes (3)

• Number of deaths

  from the time of enrollment to 28 days after enrollment

• Duration of mechanical ventilation (MV) or extracorporeal membrane oxygenation (ECMO) in days

  from the time of enrollment to 28 days after enrollment

• Duration of high-flow nasal oxygenation (HFNO) or noninvasive ventilation (NIV) in days

  from the time of enrollment to 28 days after enrollment

Study Arms (3)

Vadadustat 900mg

EXPERIMENTAL

Drug: Vadadustat 900mg

Vadadustat 1200mg

EXPERIMENTAL

Drug: Vadadustat 1200mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

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 900mg

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.

Vadadustat 1200mg

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the definition of nonintubated ARDS per the 2024 Global Definition of ARDS that includes all the following (2A-2D):
• A. 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\*\* \[\*Pneumonia defined as known or suspected based on treating physician documentation or discussion, OR both of the following criteria: 1) Chest radiography with new infiltrates, consolidation, or cavitation and (2) Clinical signs of pneumonia (new cough, sputum, fever, or white blood cells (WBC) \> 12,000)\] \[\*\*Non-pulmonary infection defined as suspected or proven infection meeting any of the following criteria: treating clinician suspects a viral, bacterial, or fungal infection, or cultures ordered in the past 24h or positive cultures within 1 week; or orders for antimicrobial medication.\]
• B. 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
• C. 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.
• D. 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
• 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

Sponsors & Collaborators

• Bentley J. Bobrow: lead
• Akebia Therapeutics Inc.: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

vadadustat

Study Officials

• Paul Potnuru, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Potnuru, MD

CONTACT

713-500-6271; Paul.Potnuru@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)