ZG-801 Phase II Trial - Exploratory Study of Efficacy and Safety on Patients With Hyperkalemia, and Long Term Safety Study

Zeria Pharmaceutical Co., Ltd.0 个研究点目标入组 180 人开始时间: 2019年2月4日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Informed consent given
•- Serum Potassium measurement at baseline is 5.1 to < 6.5 mEq/L (Nondialysis patients) or 5.5 to < 6.5 mEq/L (Dialysis patients)

•- Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months
•- Subjects with severe heart failure, defined as NYHA (New York Heart Association) class IV
•- Subjects with uncorrected hemodynamically significant primary vascular disease or uncontrolled or hemodynamically unstable arrhythmia
•- Subjects with coronary artery bypass graft, percutaneous intervention, or major surgery including thoracic and cardiac, within the previous 3 months or anticipated need during study participation
•- Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient, or anticipated need for transplant during the study period
•- Subjects with any of the significant cardiovascular or cerebrovascular events within the previous 2 months
•- Subjects with a history of or current diagnosis of a severe swallowing disorder, moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
•- Subjects who cannot use the oral concomitant medication to be separate 3 hours from ZG-801 medication
•- Subjects suspected of transient high potassium levels, such as those caused only by dietary effects

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