Clinical Trials | KOURAGE: A clinical study for Hospitalized Patients with Acute Kidney Injury (AKI) associated with acute hypoxemic respiratory failure (AHRF)

Auxora for the Treatment of AKI and Modulation of Injurious “Crosstalk” with the Lung: A Randomized Control Trial (KOURAGE) Auxora is a potent and selective small molecule inhibitor of Orai1-containing calcium release- activated calcium (CRAC) channels that is being developed for use in patients with acute inflammatory and immunologic illnesses. Auxora has the potential to reduce tissue cell injury and allow patients to eat solid food again faster and without additional pain or vomiting. 150 patients will be randomized 1:1 into KOURAGE across the USA. Patients will receive Auxora or a matching placebo infusion every 24 hours for 5 consecutive days. Study participation will end 90 days after the start of study drug. Subjects will be called at 720 hours (Day 30) for a follow-up phone call and they will be asked to complete either an in-clinic or at home follow-up visit at Day 90. Study Eligibility • Adults with Stage 2 or Stage 3 AKI, and have • Diagnosis of AHRF as defined by PaO2/FiO2 /= 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation • Must NOT have a do not intubate directive • Must NOT have chronic lung disease that requires supplemental non-invasive oxygen as an outpatient or home mechanical ventilation (excluding sleep apnea) • Must NOT have been hospitalized in an ICU for more than 10 days or on continuous invasive mechanical ventilation > 5 days prior to screening • Must NOT be taking Immunosuppressives (corticosteroid use is permitted) • Must NOT be participating in another study of an investigational drug For more study information or to refer a potential patient please contact: Emergency Medicine Research Office via Vocera or PIC 1044