CalciMedica announced that the first patient has been dosed in KOURAGE, the company’s Phase 2 trial evaluating Auxora for the treatment of severe acute kidney injury with associated acute hypoxemic respiratory failure. KOURAGE is a randomized, double-blind, placebo-controlled study expected to enroll approximately 150 patients with Stage 2 and 3 AKI who have AHRF and will randomize patients to receive 5 daily doses of Auxora or placebo. The study will assess patients up to day 30 following the final dosing to evaluate the number of days alive without the need for a ventilator or dialysis. The study’s secondary endpoints will include a composite measure of all-cause mortality, decline in estimated glomerular filtration rate and the occurrence of dialysis over a 90-day period. Topline data from KOURAGE are expected in 2025.
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