Vadadustat for nonintubated ARDS caused by infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Hospitalized patients with nonintubated ARDS attributed to a suspected pathogen-associated lung injury are assigned to receive one of two doses of oral vadadustat or placebo. The combined Phase 2/Phase 3 design examines dosing, clinical efficacy, and safety signals. Key outcomes include oxygenation (PaO2:FiO2), progression to mechanical ventilation, clinical status, and adverse events. The trial is led at The University of Texas Health Science Center at Houston in collaboration with Akebia Therapeutics.

Why it matters

Who can join: the full rules

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
* 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's running

• The University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Paul Potnuru, MD — The University of Texas Health Science Center, Houston
• Study coordinator: Paul Potnuru, MD
• Email: Paul.Potnuru@uth.tmc.edu
• Phone: 713-500-6271

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Circadian Variation of Anti-Factor Xa in Trauma Patients on LMWH

  This study tests whether anti-Factor Xa levels show a daily rhythm in hospitalized trauma patients receiving LMWH for VTE prevention.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT07856641

• PrioritiesAI: A chat tool to help older adults with hernia decide what matters most for surgery

  This study tests an AI-powered chat assistant to help people with hernia clearly express and communicate their health goals for elective surgery.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT07848386

• Family-based program to reduce risk factors for schizophrenia spectrum disorders in youth with family history

  This study tests a brief family-based psychosocial program to see if it lowers persistent psychotic-like experiences in kids and young adults with a family history of SSD and different brain risk patterns.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT07743645

• EUS-Guided RFA for Pancreatic Lesions: Safety and Outcomes

  This study tests whether using endoscopic ultrasound-guided radiofrequency ablation is safe and helps patients with pancreatic lesions.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT07737171

• Skin-to-skin care with the Skincubator for preterm infants

  This study tests whether using the Skincubator during skin-to-skin care is safe and feasible for preterm babies and their parents in the NICU.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT07721662

• See if iCHAMPSS 2.0 helps schools spread effective sexual health programs

  This study tests whether iCHAMPSS 2.0 helps Texas schools implement an evidence-based sexual health program more effectively for teachers, administrators, and health staff.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT07679620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.