A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk"
NCT ID: NCT06374797
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2024-07-01
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)
NCT04678505
Auryxia (Ferric Citrate) Therapy for In-Center and Home Dialysis Participants
NCT04922645
Renal Impairment Study of PF-06700841
NCT04260464
A Study to Investigate the Safety, Tolerability, and Preliminary Efficacy with AION-301 Administered by Intravenous Infusion Compared with Placebo Administered by Intravenous Infusion Investigational Intervention in Participants Aged 35 to 75 Years of Age with Chronic Kidney Disease (CKD)
NCT06721143
Lumasiran in Hyperoxalaemic Patients on Haemodialysis
NCT06225544
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Auxora
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CalciMedica, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sudarshan Hebbar, MD, Chief Medical Officer
Role: STUDY_DIRECTOR
CalciMedica, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Lundquist Institute for Biomedical Innovation at UCLA-Harbor Medical Center
Torrance, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Sarasota Memorial
Sarasota, Florida, 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
University of Maryland
Baltimore, Maryland, United States
Brigham & Woman's Hospital
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford
Detroit, Michigan, United States
My Michigan Health
Midland, Michigan, United States
Regions Hospital
Saint Paul, Minnesota, 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
Northshore University Hospital
New Hyde Park, 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
Long Island Jewish Medical Center
Queens, 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
Houston Methodist
Houston, Texas, United States
UT Houston
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CMZ-207
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.