Sponsor: CalciMedica, Inc. | Status: Recruiting
Start Date: 06/21/2024 | End Date: -
Principal Investigator(s)
Gentry Wilkerson
Secondary Investigator(s)
Mark Sutherland
Description:
Study Treatments
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. 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 study drug will be administered intravenously as a continuous infusion over 4 hours via a bag and tubing compatible with lipid emulsions and using a 1.2-micron filter. IV gauge 20 or greater is recommended. Patients will remain hospitalized as per standard of care. Study staff will perform study-specific hospital assessments immediately prior to the first infusion of study drug, and then every 24 hours after until 720 hours (Day 30), or until discharge if earlier.
Primary Endpoint
Days alive, ventilator free, and KRT free from SFISD through Day 30
Secondary Endpoints
Major adverse kidney event (MAKE) 90-1: ≥ 25% decline in eGFR from
baseline, incident KRT, and all-cause mortality at 90 days
MAKE 90-2: ≥ 35% decline in eGFR from baseline, incident KRT, and allcause mortality at 90 days
Proportion of patients alive at Day 30 and Day 90
Days alive and ventilator free from SFISD through Day 30
Days alive and KRT free from SFISD through Day 30
Proportion of patients recovered from AHRF through Day 30 as categorized
by an 8-point ordinal scale
Proportion of patients receiving KRT at Day 30 and Day 90
Concomittant Medications and Instructions
The following medications should be held during the 5 days the study drug is being administered to include: • Fenofibrate • Ezetimibe and • Statins. They may be resumed 24 hours after the last dose of study drug.
Any other medication, with the exception of those listed below, may be given at the discretion of the investigator.
Immunosuppressive medications/immunotherapy that should not be administered during the study include: • Chemotherapy • Cyclosporine, Tacrolimus • Sirolimus, Everolimus • Azathioprine • Cyclosphosphamide • Methotrexate • Mycophenolate • Leflunomide • Biologics/Monoclonals: such as, but not limited to, abatacept, adalimumab, alemtuzumab, anakinra, basilizimab, belimumab, bevacizumab, brodalumab, canakinumab, certolizumab, cetuximab, clazakizumab, daclizumab, eculizumab, etanercept, golimumab, guselkumab, infliximab, interferon, ixekizumab, muromonab, natalizumab, omalizumab, rituximab, secukinumab, tocilizumab, trastuzumab, ustekinumab, vedolizumab, • Baracitinib