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Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

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

NCT07086755•Bentley J. Bobrow

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+10 more criteria

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

October 23, 2025

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

December 17, 2025

Enrollment

1,100

ESTIMATED participants

Conditions

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

Interventions

Vadadustat 900mg

DRUG

Vadadustat 1200mg

DRUG

Placebo

DRUG

Contacts

Paul Potnuru, MD

CONTACT

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