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

NCT06374797 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CMZ-207
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 33

Brief 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.

Conditions

Acute Kidney Injury

Keywords

AKI; Acute Kidney Injury; Auxora

Outcome Measures

Primary Outcomes (1)

• Days alive, ventilator-free and kidney replacement therapy (KRT)-free from SFISD through Day 30

  The primary efficacy analysis will apply the win ratio method and the Finkelstein-Schoenfeld method to the primary endpoints. The win ratio method allocates all Auxora and placebo pairs to the components that comprise the primary endpoint in a hierarchical fashion. Categories (a) and (c) represent Auxora wins based on all-cause mortality and days ventilator-free and KRT-free. Similarly, categories (b) and (d) represent placebo wins. Category (e) represents ties. (a) Death on placebo, but alive on Auxora at day 30 (b) Death on Auxora, but alive on placebo at day 30 (e) Death on placebo and death on Auxora at day 30 If alive on placebo and alive on Auxora at day 30: (c) Greater number of days alive, ventilator-free and KRT-free on Auxora (d) Greater number of days alive, ventilator-free and KRT-free on Placebo (e) Equal number of days alive, ventilator-free and KRT-free We will calculate the overall win ratio by adding (a) + (c) and dividing it by the sum of (b) + (d).

  SFISD through Day 30

Secondary Outcomes (11)

• Major adverse kidney event (MAKE) 90-1: ≥25% decline in estimated glomerular filtration rate (eGFR) from baseline, incident KRT, and all-cause mortality at 90 days

  At Day 90

• MAKE 90-2: ≥35% decline in eGFR from baseline, incident KRT, and all-cause mortality at 90 days

  At Day 90

• Proportion of patients alive at Day 30

  At Day 30

• Proportion of patients alive at Day 90

  Day 90

• Days alive and ventilator-free from start of first infusion of study drug (SFISD) through Day 30

  SFISD through Day 30

Other Outcomes (3)

• Days alive and not hospitalized through Day 30

  SFISD through Day 30

• Proportion of patients re-hospitalized through Day 30

  SFISD through Day 30

• Proportion of patients re-hospitalized through Day 90

  SFISD through Day 90

Study Arms (2)

Auxora

EXPERIMENTAL

Drug: Auxora

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Auxora DRUG

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.

Auxora

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is ≥ 18 years of age.
• The patient has developed Stage 2 or Stage 3 AKI.
• 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
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• The patient has a do not intubate directive.
• The patient has been hospitalized in the ICU for more than 10 days.
• The patient has been receiving invasive mechanical ventilation for \> 120 hours.
• The patient is receiving extracorporeal membrane oxygen (ECMO).
• The patient has started or is planned to start kidney replacement therapy (KRT) before randomization.
• The patient has a serum triglyceride level ≥ 500 mg/dL.
• 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.
• 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.
• The patient has a known history of an organ transplant.
• The patient has a known history of HIV infection.
• The patient has known history of hepatitis B infection.
• The patient is currently receiving chemotherapy.
• The patient is currently receiving immunosuppressive medications
• The patient is known to be pregnant or is currently nursing.
• The patient is allergic to eggs.

Sponsors & Collaborators

• CalciMedica, Inc.: lead

Study Sites (33)

University of Alabama

Birmingham, Alabama, 35249, United States

Location

Chandler Regional Hospital

Chandler, Arizona, 85224, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Stanford Health Care

Stanford, California, 94304, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90502, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Tampa General

Tampa, Florida, 33606, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

St Luke's Hospital

Boise, Idaho, 83712, United States

Location

Northwestern University-Pulmonary & Critical Care Medicine

Chicago, Illinois, 60611, United States

Location

University of Indiana

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52243, United States

Location

Brigham & Woman's Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Henry Ford

Detroit, Michigan, 48202, United States

Location

My Michigan Health

Midland, Michigan, 48670, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Hannibal Regional

Hannibal, Missouri, 63401, United States

Location

Holy Name

Teaneck, New Jersey, 07666, United States

Location

NYU Langone Health - Brooklyn

Brooklyn, New York, 11220, United States

Location

NYU Langone Health - Bellview

New York, New York, 10016, United States

Location

NYU Langone Health - Tisch Hospital

New York, New York, 10016, United States

Location

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44095, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43202, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor Scott and White Research Institute

Dallas, Texas, 75246, United States

Location

UT Houston

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

zegocractin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sudarshan Hebbar, MD, Chief Medical Officer

  CalciMedica, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (33)