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ACTIVE NOT RECRUITING
NCT06374797
PHASE2

A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk"

Sponsor: CalciMedica, Inc.

View on ClinicalTrials.gov

Summary

Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions.

Official title: Auxora for the Treatment of AKI and Modulation of Injurious "Crosstalk" With the Lung: A Randomized Control Trial (KOURAGE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-07-01

Completion Date

2026-04

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DRUG

Auxora

1.25 mL/kg (2.0 mg/kg of zegocractin) intravenously (IV) over 4 hours at 0 hours, and then 1.0 mL/kg (1.6 mg/kg of zegocractin) IV over 4 hours at 24, 48, 72 and 96 hours for a total of 5 doses.

DRUG

Placebo

1.25 mL/kg IV over 4 hours at 0 hours and then 1.0 mL/kg IV over 4 hours at 24, 48, 72, and 96 hours for a total of 5 doses.

Locations (34)

University of Alabama

Birmingham, Alabama, United States

Chandler Regional Hospital

Chandler, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

UCLA

Los Angeles, California, United States

Stanford Health Care

Stanford, California, United States

Torrance Memorial Medical Center

Torrance, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Tampa General

Tampa, Florida, United States

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

St Luke's Hospital

Boise, Idaho, United States

Northwestern University-Pulmonary & Critical Care Medicine

Chicago, Illinois, United States

University of Indiana

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Brigham & Woman's Hospital

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Henry Ford

Detroit, Michigan, United States

My Michigan Health

Midland, Michigan, United States

University of Missouri

Columbia, Missouri, United States

Hannibal Regional

Hannibal, Missouri, United States

Holy Name

Teaneck, New Jersey, United States

NYU Langone Health - Brooklyn

Brooklyn, New York, United States

NYU Langone Health - Bellview

New York, New York, United States

NYU Langone Health - Tisch Hospital

New York, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Cleveland Clinic Akron General

Akron, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baylor Scott and White Research Institute

Dallas, Texas, United States

UT Houston

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States