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A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk"
Sponsor: CalciMedica, Inc.
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
Conditions
Interventions
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.
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