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New treatment option for Nonintubated Acute Respiratory Distress Syndrome (ARDS)
Official title Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury
ClinicalTrials.gov ID: NCT07086755
What this study is testing
What is Vadadustat 900mg?
Vadadustat 900mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nonintubated acute respiratory distress syndrome (ards).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- -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...
- 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...
- 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...
- 2D. Chest imaging: Chest infiltrates on radiography and computed tomography or B lines and/or consolidations on ultrasound not fully explained by...
You likely can't join 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
See the full eligibility 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...
- 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...
- 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.
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.