Hyperkalemia
Conditions
Interventions
investigational material(s)
Generic name etc : Patiromer
INN of investigational material : ZG-801
Therapeutic category code : 219 Other cardiovascular agents
Dosage and Administration for Investigatio
Sponsors
Zeria Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Change in serum potassium 4 weeks after the start of administration in each group of starting dose efficacy Proportion of subjects with a normalized serum potassium level at 4 weeks after the start of administration in each group of starting dose safety Incidence of adverse events safety Incidence of adverse drug reactions | — |
Countries
Japan
Outcome results
None listed