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

NCT07086755 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2025-12-17

No results posted yet for this study

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

Interventions

DRUG

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.

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.

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.

Sponsors & Collaborators

  • Akebia Therapeutics Inc.

    collaborator UNKNOWN

  • Bentley J. Bobrow

    lead OTHER

Principal Investigators

  • Paul Potnuru, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-23
Primary Completion
2026-07-01
Completion
2026-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07086755 on ClinicalTrials.gov