ZG-801 Phase II Trial - Exploratory Study of Efficacy and Safety on Patients With Hyperkalemia, and Long Term Safety Study -
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose
研究概览
简要总结
To investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients.
To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ages 18 - 80
- •Informed consent given
- •Serum Potassium measurement at baseline is 5.1 to < 6.5 mEq/L (Non-dialysis patients or 5.5 to < 6.5 mEq/L (Dialysis patients)
排除标准
- •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
研究组 & 干预措施
Stratum 1: 8.4 g patiromer
Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
干预措施: patiromer (Drug)
Stratum 1: 16.8 g patiromer
Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
干预措施: patiromer (Drug)
Stratum 1: placebo of 8.4 g patiromer
Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
干预措施: placebo (Drug)
Stratum 2: 16.8 g patiromer
Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline
干预措施: patiromer (Drug)
Stratum 1: placebo of 16.8 g patiromer
Non-dialysis subjects with serum potassium 5.1 to < 6.0 mEq/L range at baseline
干预措施: placebo (Drug)
Stratum 2: 8.4 g patiromer
Non-dialysis subjects with serum potassium 6.0 to < 6.5 mEq/L range at baseline
干预措施: patiromer (Drug)
Stratum 3: 8.4 g patiromer
Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline
干预措施: patiromer (Drug)
Stratum 3: 16.8 g patiromer
Dialysis subjects with serum potassium 5.5 to < 6.5 mEq/L range at baseline
干预措施: patiromer (Drug)
结局指标
主要结局
Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose
时间窗: Baseline to week 1
次要结局
- Change in serum potassium 4 weeks after the start of administration in each group of starting dose(Baseline to week 4)
- Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose(Week 4)
- Incidence of adverse drug reactions(Over 52-week study period)
- Incidence of adverse events(Over 52-week study period)