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New drug aimed at Kidney-Lung crisis shows promise in trial

NCT ID NCT06374797

Disease control Sponsor: CalciMedica, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This study tests an experimental drug called Auxora in 150 adults with acute kidney injury and breathing failure. Patients receive either Auxora or a placebo daily for five days. The goal is to see if Auxora helps patients survive, breathe without a machine, and avoid kidney dialysis for 30 days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

122 people

The number who actually took part.

Started

Jul 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. Exclusion Criteria: 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

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Conditions

The condition(s) this trial relates to.

acute kidney injury acute respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury

Contacts and locations

Locations

  • Baylor Scott and White Research Institute

    Dallas, Texas, 75246, United States

  • Brigham & Woman's Hospital

    Boston, Massachusetts, 02115, United States

  • Chandler Regional Hospital

    Chandler, Arizona, 85224, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44095, United States

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307, United States

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Hannibal Regional

    Hannibal, Missouri, 63401, United States

  • Henry Ford

    Detroit, Michigan, 48202, United States

  • Holy Name

    Teaneck, New Jersey, 07666, United States

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • My Michigan Health

    Midland, Michigan, 48670, United States

  • NYU Langone Health - Bellview

    New York, New York, 10016, United States

  • NYU Langone Health - Brooklyn

    Brooklyn, New York, 11220, United States

  • NYU Langone Health - Tisch Hospital

    New York, New York, 10016, United States

  • Northwestern University-Pulmonary & Critical Care Medicine

    Chicago, Illinois, 60611, United States

  • St Luke's Hospital

    Boise, Idaho, 83712, United States

  • Stanford Health Care

    Stanford, California, 94304, United States

  • Tampa General

    Tampa, Florida, 33606, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • The Ohio State University

    Columbus, Ohio, 43202, United States

  • Torrance Memorial Medical Center

    Torrance, California, 90502, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • UT Houston

    Houston, Texas, 77030, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama

    Birmingham, Alabama, 35249, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • University of Indiana

    Indianapolis, Indiana, 46202, United States

  • University of Iowa

    Iowa City, Iowa, 52243, United States

  • University of Missouri

    Columbia, Missouri, 65212, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.