Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT07086755

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

Led by Bentley J. Bobrow · Updated on 2025-12-17

1100

Participants Needed

1

Research Sites

35 weeks

Total Duration

On this page

Sponsors

B

Bentley J. Bobrow

Lead Sponsor

A

Akebia Therapeutics

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meets the 2024 Global Definition of nonintubated ARDS including all: risk factors from suspected pathogen-associated infection such as pneumonia or non-pulmonary infection
  • Oxygenation criteria: PaO2:FIO2 ≤ 300 mm Hg or SpO2:FIO2 ≤ 315 (if SpO2 ≤ 97%) on high-flow nasal oxygen ≥ 30 L/min or non-invasive ventilation with at least 5 cm H2O pressure
  • Acute onset or worsening of hypoxemic respiratory failure within 1 week of risk factor onset or new/worsening respiratory symptoms
  • Chest imaging showing infiltrates or ultrasound findings consistent with ARDS not explained by other causes
Not Eligible

You will not qualify if you...

  • Allergy to vadadustat or its ingredients
  • Already on mechanical ventilation before randomization
  • Receiving home oxygen therapy
  • More than 72 hours since hospital admission order placed
  • Hemoglobin above 16 g/dL for females or 18 g/dL for males at randomization
  • AST or ALT liver enzymes more than 5 times the upper normal limit
  • AST or ALT more than 3 times normal with total bilirubin over 2 times normal
  • Presence of erythrocytosis or polycythemia vera
  • Uncontrolled high blood pressure
  • Active cancer
  • Liver cirrhosis or acute liver disease
  • Taking erythropoiesis-stimulating agents
  • Taking probenecid, rifampicin, gemfibrozil, or teriflunomide
  • Pregnant, breastfeeding, or positive pregnancy test before randomization
  • Prisoner status
  • Enrolled in another interventional clinical trial
  • History of arterial or venous blood clots within past 3 months
  • History of heart attack, stroke, or acute coronary syndrome within past 3 months
  • Known or suspected tuberculosis infection
  • Expected not to survive beyond 48 hours

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

P

Paul Potnuru, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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