This clinical trial consists of 2 parts, Part A and Part B. Part A consists of a 2-day randomized, double-blind, placebo-controlled corrective phase (CP) and a 28-day randomized, double-blind, placebo-controlled maintenance phase (MP). Part B (open-label extension, OLE) is an open-label, 11-month extension study carried out in participants who come from Part A and meet certain inclusion criteria.
Eligible participants with hyperkalemia will first be randomized in a 5:1 ratio to receive oral WS016 (12g) or placebo three times daily, for a total of six doses over 48 hours. After the 48-hour corrective treatment, participants whose serum potassium is within the normal range will be re-randomized in a 1:1:1:1 ratio to receive oral WS016 (6g, 12g, or 18g) or placebo once daily for 28 consecutive days. Participants who complete the 28-day maintenance phase or prematurely discontinue from it due to hyperkalemia or hypokalemia, and who meet the eligibility criteria, will be eligible to enter Part B. In Part B, participants will receive WS016 for 11 months, starting at 12g once daily, with subsequent dose adjustments based on serum potassium levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
Mean serum potassium level during maintenance phase Days 8-29
Time frame: Maintenance phase Days 8-29
Exponential rate of change in serum potassium during the corrective phase
Time frame: Through 48 hours corrective phase
Mean change from baseline in serum potassium at all time points of corrective phase
Time frame: Through 48 hours corrective phase
Cumulative duration (in days) of serum potassium within the normal range during the maintenance phase
Time frame: Maintenance phase baseline to maintenance phase Day 29
Mean change from baseline in serum potassium at all time points of maintenance phase
Time frame: Through 28 days maintenance phase
Percentage of participants with the mean serum potassium ≤5.0 mmol/L and percentage of participants with the mean serum potassium ≤5.5 mmol/L from D8 to D337 of the open-label extension phase
Time frame: Open-label extension phase Days 8-337
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Placebo, oral, once daily for 28 consecutive days.
WS016, oral, once daily for 11 months, starting at a dose of 12g with subsequent dose adjustments based on serum potassium levels.
Investigator Site 02
Bengbu, Anhui, China
RECRUITINGInvestigator Site 03
Wuhu, Anhui, China
RECRUITINGInvestigator Site 48
Chongqing, Chongqing Municipality, China
RECRUITINGInvestigator Site 04
Xiamen, Fujian, China
RECRUITINGInvestigator Site 05
Lanzhou, Gansu, China
RECRUITINGInvestigator Site 07
Guangzhou, Guangdong, China
RECRUITINGInvestigator Site 06
Zhanjiang, Guangdong, China
RECRUITINGInvestigator Site 08
Huizhou, Guangxi, China
RECRUITINGInvestigator Site 09
Nanning, Guangxi, China
RECRUITINGInvestigator Site 10
Nanning, Guangxi, China
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