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

Last updated: June 16, 2025
Sponsor: CalciMedica, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Kidney Disease

Kidney Failure

Renal Failure

Treatment

Auxora

Placebo

Clinical Study ID

NCT06374797
CMZ-207
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 inspiredoxygen [FiO2] (P/F) ≤ 300 in the prior 24 hours, either imputed from SpO2 orobtained from an arterial blood gas, that is not explained by cardiogenic pulmonaryedema or volume overload

  4. The patient is being treated with either high flow nasal cannula with minimum flowrate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanicalventilation at time of randomization.

  5. A female patient of childbearing potential who is sexually active with a malepartner is willing to practice acceptable methods of birth control for 30 days afterthe last dose of study drug.

  6. A male patient who is sexually active with a female partner of childbearingpotential is willing to practice acceptable methods of birth control for 30 daysafter the last dose of study drug. A male patient must not donate sperm for 30 daysafter 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 cooperatewith all aspects of the protocol.

Exclusion

Exclusion Criteria:

  1. The patient has a do not intubate directive.

  2. The patient has chronic lung disease that requires supplemental non-invasive oxygenas an outpatient or home mechanical ventilation. The use of non-invasive mechanicalventilation 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 urinarytract 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

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Auxora
Phase: 2
Study Start date:
July 01, 2024
Estimated Completion Date:
March 31, 2026

Study Description

This double blind, randomized, placebo-controlled study will evaluate the efficacy, safety, and tolerability of Auxora in patients with severe AKI who have associated AHRF. The definition of AKI and the stages of AKI will be based on the classification system proposed by the Acute Kidney Injury Working Group of Kidney Disease: Improving Global Outcomes (KDIGO) and incorporate both serum creatinine and urine volume criteria. AHRF will be defined as a P/F ≤ 300 that has been determined by either an arterial blood gas or imputed from the oxygen saturation (SpO2) recorded using pulse oximetry 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. Approximately 150 patients with severe AKI, defined as having developed either stage 2 or 3 AKI at the time of consent, who have associated AHRF will be randomized 1:1 into either the Auxora or placebo group using a computer-generated randomization scheme accessed through an interactive voice/web response system (IXRS). Randomization will be stratified by the use of invasive mechanical ventilation and by Stage 3 AKI.

Patients who are randomized to the Auxora group will receive 1.25 mL/kg (2.0 mg/kg of zegocractin) 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. Patients who are randomized to the placebo group will receive 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. Placebo will be a matching emulsion without the active pharmaceutical ingredient zegocractin. The sponsor, investigators, pharmacists, and patients will be blinded to the assigned group. The Start of First Infusion of Study Drug (SFISD) should occur no more than 24 hours of the patient or legally authorized representative (LAR) providing informed consent. A study physician or appropriately trained delegate will perform study-specific hospital assessments immediately prior to the SFISD, and then every 24 hours after the SFISD until 720 hours (Day 30), or until discharge if earlier. All patients, including those that are discharged from the hospital to home, or to a skilled nursing facility, or to an extended care facility, will be assessed at Day 90.

All AKI should be managed according to the KDIGO 2012 guidelines which recommends maintaining adequate organ perfusion, avoiding volume overload, avoiding hyperglycemia, discontinuing nephrotoxic agents, and adjusting dosing of renally excreted medications. AHRF/acute respiratory distress syndrome (ARDS) should be managed according to the 2023 European Society of Intensive Care Medicine (ESICM) major recommendations.

Connect with a study center

  • University of Alabama

    Birmingham, Alabama 35249
    United States

    Active - Recruiting

  • Chandler Regional Hospital

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Stanford Health Care

    Stanford, California 94304
    United States

    Active - Recruiting

  • Lundquist Institute for Biomedical Innovation at UCLA-Harbor Medical Center

    Torrance, California 90509
    United States

    Site Not Available

  • Torrance Memorial

    Torrance, California 90502
    United States

    Active - Recruiting

  • Torrance Memorial Medical Center

    Torrance, California 90502
    United States

    Active - Recruiting

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington DC, District of Columbia 20010
    United States

    Site Not Available

  • Sarasota Memorial

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Tampa General

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Emory Johns Creek Hospital

    Johns Creek, Georgia 30097
    United States

    Active - Recruiting

  • St Luke's Hospital

    Boise, Idaho 83712
    United States

    Active - Recruiting

  • St Luke's Hospital

    Boise, Idaho 83712
    United States

    Active - Recruiting

  • Northwestern University-Pulmonary & Critical Care Medicine

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Indiana

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52243
    United States

    Active - Recruiting

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Brigham & Woman's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • My Michigan Health

    Midland, Michigan 48670
    United States

    Active - Recruiting

  • Regions Hospital

    Saint Paul, Minnesota 55101
    United States

    Site Not Available

  • University of Missouri

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Hannibal Regional

    Hannibal, Missouri 63401
    United States

    Active - Recruiting

  • NYU Langone Health - Brooklyn

    Brooklyn, New York 11220
    United States

    Active - Recruiting

  • Northshore University Hospital

    New Hyde Park, New York 11042
    United States

    Active - Recruiting

  • Northwell Health - North Shore University Hospital

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • NYU Langone Health - Bellview

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone Health - Tisch Hospital

    New York, New York 10016
    United States

    Active - Recruiting

  • Long Island Jewish Medical Center

    Queens, New York 11040
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43202
    United States

    Active - Recruiting

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Houston Methodist

    Houston, Texas 77030
    United States

    Site Not Available

  • UT Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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