The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase.
The study plan includes approximately 140 participants who will be randomly assigned to the WS016 and placebo treatment groups. Participants will begin a 48-hour acute treatment phase with three times-daily oral administrations. After the 48-hour acute treatment, participants have returned to normokalemia will be randomly assigned again to enter a 12-day maintenance treatment phase with once-daily oral administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Acute treatment phase: WS016, oral, 3g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 3g, once daily for 12 days.
Acute treatment phase: WS016, oral, 6g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 6g, once daily for 12 days.
Acute treatment phase: WS016, oral, 12g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 12g, once daily for 12 days.
Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase
Time frame: Through the initial 48-hour acute treatment phase (from baseline to hour 48)
Exponential rate of change in S-K levels during the maintenance treatment phase
Time frame: Through 12 days of maintenance treatment phase (from Day 3 to Day 15)
Mean change in S-K levels during the acute treatment phase
The mean change in S-K levels during the acute treatment phase compared to baseline
Time frame: Through the initial 48-hour acute treatment phase
Proportion of participants recover from hyperkalemia
The percentage of participants whose S-K levels return to normal during the acute treatment phase
Time frame: Through the initial 48-hour acute treatment phase
Time to normalization in S-K levels
The time(hours) it takes for participants' S-K levels to return to normal during the acute treatment phase
Time frame: Through the initial 48-hour acute treatment phase
Proportion of patients remaining normokalemic
The percentage of participants whose S-K levels remain within the normal range (3.5-5.0 mmol/L) at the end of the maintenance treatment phase
Time frame: Day 15
Mean change in S-K levels during the maintenance treatment phase
The mean change in S-K levels during the maintenance treatment phase compared to baseline
Time frame: Through 12 days of maintenance treatment phase (from Day 3 to Day 15)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Acute treatment phase: Matching Placebo, oral, three times a day for 48 hours; Maintenance treatment phase: Matching Placebo, oral, once daily for 12 days.
Peking University People's Hospital
Beijing, Beijing Municipality, China
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