To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following two days of initial ZS therapy (10g TID).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
267
Suspension administered 10g orally three times per day, in the first 48-hour of the study for all patients (48-hour open label initial phase)
Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
Least Square Mean S-K Level on Days 8-29
Comparison between placebo and the active ZS treatment groups (each dose group will be sequentially compared with placebo, starting with the highest and ending with the lowest dose) with regard to the mean S-K level during the 28-day randomized treatment study phase Days 8-29. The results in the table below are presented for RTP.
Time frame: Through 28-day randomized treatment study phase day 8-29.
Proportion of Patients Achieving Normokalemia
Proportion of patients who achieve normokalemia during the initial phase at 24 and 48 hours. The results in the table below are presented for OLP. (h=hours).
Time frame: Through 48-hour initial phase.
Exponential Rate of Change in S-K Levels
Exponential rate of change in S-K levels (blood) during the 48-hour open-label initial phase. The results in the table below are presented for OLP.
Time frame: Through 48-hour initial phase.
Absolute Change From Baseline in S-K Levels
Absolute change from baseline in S-K levels at all measured time intervals. The results in the table below are presented for OLP.
Time frame: Through 48-hour initial phase.
Percentage Change From Baseline in S-K Levels
Percentage change from baseline in S-K levels at all measured time intervals. The results in the table below are presented for OLP.
Time frame: Through 48-hour initial phase.
Proportion of Patients Remaining Normokalemic
The proportion of patients who remain normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) at the end of the 28-day randomized treatment study phase and during the 28-day randomized treatment study phase. The results in the table below are presented for RTP.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
Research Site
Chiba, Japan
Research Site
Hanyu-shi, Japan
Research Site
Hitachi-Naka, Japan
Research Site
Ina-shi, Japan
Research Site
Kanazawa, Japan
Research Site
Koga-shi, Japan
Research Site
Matsudo-shi, Japan
Research Site
Nagoya, Japan
Research Site
Nagoya, Japan
Research Site
Shimajiri-gun, Japan
...and 35 more locations
Time frame: Through 28-day randomized treatment study phase day 8-29.
Proportion of Normokalemic Patients at Day 1 Through Day 29/Exit
The proportion of patients who are normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) at Day 1 through Day 29/Exit in randomization phase. The results in the table below are presented for RTP.
Time frame: Through 28-day randomized treatment phase.
Days Patients Remain Normokalemic
The number of days patients remain normokalemic during the 28-day randomized treatment study phase. The results in the table below are presented for RTP.
Time frame: Through 28-day randomized treatment phase.
Mean Change in S-K Levels
The mean change in S-K levels evaluated relative to both baselines. The results in the table below are presented for RTP.
Time frame: Through 28-day randomized treatment phase.
Mean Percentage Change in S-K Levels
The mean percentage change in S-K levels evaluated relative to both baselines. The results in the table below are presented for RTP.
Time frame: Through 28-day randomized treatment phase.
Number of Hyperkalemic Patients
The results represent number of hyperkalemic patients during the 28-day randomized treatment study phase. The results in the table below are presented for RTP.
Time frame: Through 28-day randomized treatment phase.
Mean Changes in S-Aldosterone and P Renin Levels
The mean changes from OLP baseline in S-Aldosterone and P-Renin levels. The results in the table below are presented for RTP.
Time frame: Through 28-day randomized treatment phase.
Patient Reported Health State (EQ-5D) Questionnaire
Evaluate health state of patients using EQ-5D questionnaire. This scale is numbered from 0 to 100. 0 means the worst health you can imagine. 100 means the best health you can imagine. The results in the table below are presented for RTP.
Time frame: Through study completion, an average of 37 days.