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:2024-06-04

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status: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, and is being treated with high flow nasal cannula with minimum flow rate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation. 4. 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. 5. 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. 6. The patient is willing and able to, or has a 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 resuscitate or 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 for more than 7 days. 4. The patient has catecholamine resistant shock and has required ≥ 0.2 ug/kg/min of norepinephrine or equivalent for the prior 6 hours. 5. The patient has been receiving invasive mechanical ventilation for \> 72 hours. 6. The patient is receiving invasive mechanical ventilation and has had a FiO2 ≥ 80% documented in the previous 6 hours. 7. The patient is receiving ECMO. 8. The patient has started, or is expected to start KRT in the next 12 hours. 9. The patient has a serum triglyceride level ≥ 500 mg/dL. 10. 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. 11. 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. 12. The patient has a known history of an organ transplant. 13. The patient has a known history of HIV infection. 14. The patient has known history of hepatitis B infection. 15. The patient is currently receiving chemotherapy. 16. The patient is currently receiving immunosuppressive medications 17. The patient is known to be pregnant or is currently nursing. 18. The patient is allergic to eggs. 19. 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, and is being treated with high flow nasal cannula with minimum flow rate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation.
4. 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.
5. 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.
6. The patient is willing and able to, or has a 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 resuscitate or 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 for more than 7 days.
4. The patient has catecholamine resistant shock and has required ≥ 0.2 ug/kg/min of norepinephrine or equivalent for the prior 6 hours.
5. The patient has been receiving invasive mechanical ventilation for \> 72 hours.
6. The patient is receiving invasive mechanical ventilation and has had a FiO2 ≥ 80% documented in the previous 6 hours.
7. The patient is receiving ECMO.
8. The patient has started, or is expected to start KRT in the next 12 hours.
9. The patient has a serum triglyceride level ≥ 500 mg/dL.
10. 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.
11. 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.
12. The patient has a known history of an organ transplant.
13. The patient has a known history of HIV infection.
14. The patient has known history of hepatitis B infection.
15. The patient is currently receiving chemotherapy.
16. The patient is currently receiving immunosuppressive medications
17. The patient is known to be pregnant or is currently nursing.
18. The patient is allergic to eggs.
19. The patient is currently participating in another study of an investigational drug

Contacts and Locations

Study Contact

Katherine Randolph

CONTACT

619-665-5106

Katherine@calcimedica.com

Andrew Cunningham, MD

CONTACT

617-335-9196

Andy@calcimedica.com

Principal Investigator

Sudarshan Hebbar, MD, Chief Medical Officer

STUDY_DIRECTOR

CalciMedica, Inc.

Study Locations (Sites)

Torrance Memorial Medical Center

Torrance, California, 90502

United States

Lundquist Institute for Biomedical Innovation at UCLA-Harbor Medical Center

Torrance, California, 90509

United States

St Luke's Hospital

Boise, Idaho, 83712

United States

Northwestern University-Pulmonary & Critical Care Medicine

Chicago, Illinois, 60611

United States

University of Iowa

Iowa City, Iowa, 52243

United States

University of Maryland

Baltimore, Maryland, 21201

United States

Brigham & Woman's Hospital

Boston, Massachusetts, 02115

United States

Henry Ford

Detroit, Michigan, 48202

United States

University of Missouri

Columbia, Missouri, 65212

United States

Northwell Health - North Shore University Hospital

New Hyde Park, New York, 11042

United States

The Ohio State University

Columbus, Ohio, 43202

United States

Houston Methodist

Houston, Texas, 77030

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 Date2024-06-04

Study Completion Date2025-08

Study Record Updates

Study Start Date2024-06-04

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

AKI
Acute Kidney Injury
Auxora

Additional Relevant MeSH Terms

Acute Kidney Injury