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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
184
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)
Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
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)
Zeria Investigative Sites
Kanagawa, Japan
Change in serum potassium from baseline to 1 week after the start of administration in each group of starting dose
Time frame: Baseline to week 1
Change in serum potassium 4 weeks after the start of administration in each group of starting dose
Time frame: 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
Time frame: Week 4
Incidence of adverse events
Time frame: Over 52-week study period
Incidence of adverse drug reactions
Time frame: Over 52-week study period
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Placebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)
Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)