The purpose of this study is to evaluate the superiority of ZG-801 to placebo in Japanese hyperkalemia patients whose serum potassium value becomes normal in the Run-in period by comparing the change in the value at the Double-blind period week 4, and to further evaluate the efficacy and safety of ZG-801 in Japanese hyperkalemia patients administrated ZG-801 for maximum 9 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
ZG-801 is powder for suspension. In Run-in period, ZG-801 is taken once a day for 4 or 5 weeks. In Double-blind period, ZG-801 is taken once a day for 4 weeks.
Placebo is powder for suspension. In Double-blind period, Placebo is taken once a day for 4 weeks.
Zeria Investigative Site
Hitachi-Naka, Ibaraki, Japan
Change in serum potassium value at Double-blind period week4
Time frame: Double-blind period baseline to Double-blind period week4
Maintenance of serum potassium value within 3.5 mEq/L to < 5.1 mEq/L or within 3.5 mEq/L to <5.5 mEq/L in Double-blind Period
Time frame: Double-blind period baseline to Double-blind period week4
Time to First Non-maintenance of Serum Potassium Value in Double-blind Period
Time frame: Double-blind period baseline to Double-blind period week4
RAASi dose sustaining proportion
Time frame: Double-blind period baseline to Double-blind period week4
Change in Serum Potassium Value
Time frame: Run-in period baseline to Run-in period week 5
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