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

NCT ID: NCT07086755

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-23
• Study Completion Date: 2026-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vadadustat 900mg

Group Type: EXPERIMENTAL

Vadadustat 900mg

Intervention Type: 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 1200mg

Group Type: EXPERIMENTAL

Vadadustat 1200mg

Intervention Type: 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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Vadadustat 900mg

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.

Intervention Type: DRUG

Vadadustat 1200mg

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akebia Therapeutics Inc.

UNKNOWN

Sponsor Role: collaborator

Bentley J. Bobrow

OTHER

Sponsor Role: lead

Responsible Party

Bentley J. Bobrow

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paul Potnuru, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul Potnuru, MD

Role: CONTACT

Paul.Potnuru@uth.tmc.edu

713-500-6271

Facility Contacts

Paul J. Potnuru, MD

Role: primary

Paul.Potnuru@uth.tmc.edu

713-500-6271

Other Identifiers

HSC-MS-22-0260

Identifier Type: -

Identifier Source: org_study_id