Exploratory Study of ZG-801 for the Treatment of Hyperkalemia
- Registration Number
- NCT03799926
- Lead Sponsor
- Zeria Pharmaceutical
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stratum 1: 16.8 g patiromer patiromer Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline Stratum 2: 16.8 g patiromer patiromer Non-dialysis subjects with serum potassium 6.0 to \< 6.5 mEq/L range at baseline Stratum 3: 16.8 g patiromer patiromer Dialysis subjects with serum potassium 5.5 to \< 6.5 mEq/L range at baseline Stratum 1: 8.4 g patiromer patiromer Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline Stratum 1: placebo of 8.4 g patiromer placebo Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline Stratum 1: placebo of 16.8 g patiromer placebo Non-dialysis subjects with serum potassium 5.1 to \< 6.0 mEq/L range at baseline Stratum 3: 8.4 g patiromer patiromer Dialysis subjects with serum potassium 5.5 to \< 6.5 mEq/L range at baseline Stratum 2: 8.4 g patiromer patiromer Non-dialysis subjects with serum potassium 6.0 to \< 6.5 mEq/L range at baseline
- Primary Outcome Measures
Name Time Method Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose Baseline to week 1
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Zeria Investigative Sites
🇯🇵Kanagawa, Japan