Chawla Lakhmir S, Murray Patrick T, Goldstein Stuart L, Cunningham Andrew, Hebbar Sudarshan, Wunderink Richard G, Chertow Glenn M
Veterans Affairs Medical Center, San Diego, California, USA.
School of Medicine, University College Dublin, Dublin, Ireland.
Am J Nephrol. 2025 Jun 9:1-11. doi: 10.1159/000546863.
Patients with severe acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF) experience poorer outcomes, including higher rates of in-hospital mortality, relative to patients with less severe AKI, or those without associated AHRF. Zegocractin is a calcium release-activated calcium (CRAC) channel inhibitor with potent anti-inflammatory and pulmonary endothelial protective properties. Preclinical and early phase clinical studies suggest that zegocractin may be an effective agent for the treatment of AKI.
KOURAGE (NCT06374797) is a multicenter, phase 2, randomized, double blind, placebo-controlled trial that aims to enroll approximately 150 patients with severe AKI and AHRF. Eligible patients will be randomized 1:1 to receive a total of five daily doses of zegocractin intravenous emulsion (Auxora™) or matching placebo. The objective was to evaluate the safety and efficacy of Auxora in patients with severe AKI, with the primary efficacy endpoint defined as the number of days alive, ventilator-free and kidney replacement therapy-free from the start of the first infusion of the study drug through day 30. A key secondary efficacy endpoint is the proportion of patients with major adverse kidney events at day 90.
The KOURAGE trial will investigate the safety and efficacy of Auxora in patients with severe AKI and AHRF.
与不太严重的急性肾损伤（AKI）患者或无相关急性低氧性呼吸衰竭（AHRF）的患者相比，患有严重急性肾损伤并伴有急性低氧性呼吸衰竭的患者预后较差，包括住院死亡率更高。泽戈克拉汀是一种钙释放激活钙（CRAC）通道抑制剂，具有强大的抗炎和肺内皮保护特性。临床前和早期临床研究表明，泽戈克拉汀可能是治疗急性肾损伤的有效药物。
KOURAGE（NCT06374797）是一项多中心、2期、随机、双盲、安慰剂对照试验，旨在招募约150名患有严重急性肾损伤和急性低氧性呼吸衰竭的患者。符合条件的患者将按1:1随机分组，接受总共五剂每日一次的泽戈克拉汀静脉乳剂（Auxora™）或匹配的安慰剂。目的是评估Auxora在严重急性肾损伤患者中的安全性和有效性，主要疗效终点定义为从首次输注研究药物开始至第30天存活、无需呼吸机且无需肾脏替代治疗的天数。一个关键的次要疗效终点是第90天时发生主要不良肾脏事件的患者比例。
KOURAGE试验将研究Auxora在严重急性肾损伤和急性低氧性呼吸衰竭患者中的安全性和有效性。
