An open-label study of FCU-08 in patients with acute kidney injury requiring continuous blood purification therapy

FUSO Pharmaceutical Industries, Ltd.1 个研究点目标入组 40 人开始时间: 待定最近更新: 2020年7月30日

适应症

试验速览

暂无简介。

研究类型: Interventional
干预模型: A Multicenter, Open-label, Randomized, Active-controlled, Parallel-group Study
主要目的: Treatment Purpose

•(1) Patients diagnosed with acute kidney injury
•(2) Patients judged to need continuous renal replacement therapy by the investigator, etc.
•(3) Patients aged 20 years or older at the time of informed consent
•(4) Patients providing written informed consent about participation in this clinical trial by themselves, or legally acceptable representative if patients lack the ability of consent

•(1) Patients with serum potassium level of 5.5 mEq/L or more at the time of enrollment
•(2) Patients undergone intermittent hemodialysis, intermittent hemofiltration, intermittent hemodiafiltration more than once or continuous blood purification therapy for more than 24 hours between admission for illness caused acute kidney injury (including other hospitals) and enrollment
•(3) Patients with a platelet count of 80000/mm3 or less at the time of enrollment
•(4) Patients who have life-threatening bleeding symptoms or bleeding in regions where it is difficult to stop bleeding with cerebral hemorrhage, severe pulmonary hemorrhage, severe gastrointestinal hemorrhage, and multiple trauma complications, etc. at the time of enrollment
•(5) Patients with chronic kidney disease undergoing hemodialysis
•(6) Female patients who have the possibility of pregnancy
•(7) Patients who can be confirmed the administration of other study drug (use of investigational device) within 12 weeks before the time of enrollment, or patients in another clinical study at the time of enrollment
•(8) Patients judged to be inadequate by the investigator, etc.

safety efficacy exploratory -

未报告次要终点

发起方

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