ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-07-01

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06374797

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. The patient is ≥ 18 years of age. 2. The patient has developed Stage 2 or Stage 3 AKI. 3. The patient has a documented partial pressure of oxygen \[Pa02\]/fraction of inspired oxygen \[FiO2\] (P/F) ≤ 300 in the prior 24 hours, either imputed from SpO2 or obtained from an arterial blood gas, that is not explained by cardiogenic pulmonary edema or volume overload 4. The patient is being treated with either high flow nasal cannula with minimum flow rate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation at time of randomization. 5. A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 30 days after the last dose of study drug. 6. A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 30 days after the last dose of study drug. A male patient must not donate sperm for 30 days after the last dose of study drug. 7. The patient is willing and able to, or has a legally authorized representative (LAR) who is willing and able to, provide informed consent to participate and to cooperate with all aspects of the protocol.	1. The patient has a do not intubate directive. 2. The patient has chronic lung disease that requires supplemental non-invasive oxygen as an outpatient or home mechanical ventilation. The use of non-invasive mechanical ventilation to treat obstructive sleep apnea is not an exclusion. 3. The patient has been hospitalized in the ICU for more than 10 days. 4. The patient has been receiving invasive mechanical ventilation for \> 120 hours. 5. The patient is receiving extracorporeal membrane oxygen (ECMO). 6. The patient has started or is planned to start kidney replacement therapy (KRT) before randomization. 7. The patient has a serum triglyceride level ≥ 500 mg/dL. 8. The patient has a direct bilirubin level \>3.0 mg/dL or both a direct bilirubin level ≥ 2.0 mg/dL and an international normalized ratio (INR) ≥ 1.7. 9. AKI is suspected to be secondary to: renal artery or renal vein thrombosis; hepato-renal syndrome; cholesterol emboli syndrome; acute glomerulonephritis; vasculitis; acute allergic interstitial nephritis; intrarenal or extrarenal urinary tract obstruction; use of immune checkpoint inhibitor. 10. The patient has a known history of an organ transplant. 11. The patient has a known history of HIV infection. 12. The patient has known history of hepatitis B infection. 13. The patient is currently receiving chemotherapy. 14. The patient is currently receiving immunosuppressive medications 15. The patient is known to be pregnant or is currently nursing. 16. The patient is allergic to eggs. 17. The patient is currently participating in another study of an investigational drug

Inclusion Criteria

Exclusion Criteria

1. The patient is ≥ 18 years of age.
2. The patient has developed Stage 2 or Stage 3 AKI.
3. The patient has a documented partial pressure of oxygen \[Pa02\]/fraction of inspired oxygen \[FiO2\] (P/F) ≤ 300 in the prior 24 hours, either imputed from SpO2 or obtained from an arterial blood gas, that is not explained by cardiogenic pulmonary edema or volume overload
4. The patient is being treated with either high flow nasal cannula with minimum flow rate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation at time of randomization.
5. A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 30 days after the last dose of study drug.
6. A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 30 days after the last dose of study drug. A male patient must not donate sperm for 30 days after the last dose of study drug.
7. The patient is willing and able to, or has a legally authorized representative (LAR) who is willing and able to, provide informed consent to participate and to cooperate with all aspects of the protocol.

1. The patient has a do not intubate directive.
2. The patient has chronic lung disease that requires supplemental non-invasive oxygen as an outpatient or home mechanical ventilation. The use of non-invasive mechanical ventilation to treat obstructive sleep apnea is not an exclusion.
3. The patient has been hospitalized in the ICU for more than 10 days.
4. The patient has been receiving invasive mechanical ventilation for \> 120 hours.
5. The patient is receiving extracorporeal membrane oxygen (ECMO).
6. The patient has started or is planned to start kidney replacement therapy (KRT) before randomization.
7. The patient has a serum triglyceride level ≥ 500 mg/dL.
8. The patient has a direct bilirubin level \>3.0 mg/dL or both a direct bilirubin level ≥ 2.0 mg/dL and an international normalized ratio (INR) ≥ 1.7.
9. AKI is suspected to be secondary to: renal artery or renal vein thrombosis; hepato-renal syndrome; cholesterol emboli syndrome; acute glomerulonephritis; vasculitis; acute allergic interstitial nephritis; intrarenal or extrarenal urinary tract obstruction; use of immune checkpoint inhibitor.
10. The patient has a known history of an organ transplant.
11. The patient has a known history of HIV infection.
12. The patient has known history of hepatitis B infection.
13. The patient is currently receiving chemotherapy.
14. The patient is currently receiving immunosuppressive medications
15. The patient is known to be pregnant or is currently nursing.
16. The patient is allergic to eggs.
17. The patient is currently participating in another study of an investigational drug

Contacts and Locations

Principal Investigator

Sudarshan Hebbar, MD, Chief Medical Officer

STUDY_DIRECTOR

CalciMedica, Inc.

Study Locations (Sites)

University of Alabama

Birmingham, Alabama, 35249

United States

Chandler Regional Hospital

Chandler, Arizona, 85224

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

UCLA

Los Angeles, California, 90095

United States

Stanford Health Care

Stanford, California, 94304

United States

Torrance Memorial Medical Center

Torrance, California, 90502

United States

University of Colorado Hospital

Aurora, Colorado, 80045

United States

Tampa General

Tampa, Florida, 33606

United States

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097

United States

St Luke's Hospital

Boise, Idaho, 83712

United States

Northwestern University-Pulmonary & Critical Care Medicine

Chicago, Illinois, 60611

United States

University of Indiana

Indianapolis, Indiana, 46202

United States

University of Iowa

Iowa City, Iowa, 52243

United States

Brigham & Woman's Hospital

Boston, Massachusetts, 02115

United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805

United States

Henry Ford

Detroit, Michigan, 48202

United States

My Michigan Health

Midland, Michigan, 48670

United States

University of Missouri

Columbia, Missouri, 65212

United States

Hannibal Regional

Hannibal, Missouri, 63401

United States

Holy Name

Teaneck, New Jersey, 07666

United States

NYU Langone Health - Brooklyn

Brooklyn, New York, 11220

United States

NYU Langone Health - Bellview

New York, New York, 10016

United States

NYU Langone Health - Tisch Hospital

New York, New York, 10016

United States

Stony Brook University Hospital

Stony Brook, New York, 11794

United States

Cleveland Clinic Akron General

Akron, Ohio, 44307

United States

Cleveland Clinic

Cleveland, Ohio, 44095

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

The Ohio State University

Columbus, Ohio, 43202

United States

Geisinger Medical Center

Danville, Pennsylvania, 17822

United States

Temple University

Philadelphia, Pennsylvania, 19140

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Baylor Scott and White Research Institute

Dallas, Texas, 75246

United States

UT Houston

Houston, Texas, 77030

United States

University of Virginia

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: CalciMedica, Inc.

Sudarshan Hebbar, MD, Chief Medical Officer, STUDY_DIRECTOR, CalciMedica, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-07-01

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

AKI
Acute Kidney Injury
Auxora

Additional Relevant MeSH Terms

Acute Kidney Injury