Hyperkalemia
Conditions
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.
Interventions
DRUGpatiromer
Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
DRUGplacebo
Placebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
Sponsors
Zeria Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 events | Over 52-week study period |
| Incidence of adverse drug reactions | Over 52-week study period |
Countries
Japan
Outcome results
None listed