A Phase 3 interventional study of WS016 in Hyperkalemia, sponsored by Waterstone Pharmaceutical (Wuhan) Co., LTD.. Recruiting at 50 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Waterstone Pharmaceutical (Wuhan) Co., LTD. · Phase 3, Interventional, and Treatment
This clinical trial is an open-label, consisting of 2 phases, corrective phase (CP) and a maintenance phase (MP). The corrective phase aims to correct hyperkalemia within 24 to 72 hours, the maintenance phase aims to maintain the serum potassium level of subjects in the normal range for 12-month extension study carried out in participants who come from the first phase and meet certain inclusion criteria.
Eligible participants with hyperkalemia will first receive oral WS016 (12g) three times daily, over 24 to 72 hours.
After the corrective treatment, participants whose serum potassium is within the normal range will be enter the open-label maintenance phase to receive WS016 for 12-month, starting at 12g once daily, with subsequent dose adjustments based on serum potassium levels.
124 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's planned enrollment of 300 is above the median of 85 across 93 interventional studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →Waterstone Pharmaceutical (Wuhan) Co., LTD. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Drug: WS016
There is no other interventions in this clinical study.
Percentage of subjects with the mean serum potassium ≤5.0 mmol/L during maintenance phase
Time frame: Maintenance phase 12-month
Adverse events, serious adverse events, treatment-related adverse events, treatment-related serious adverse events and their incidences in subjects in the corrective phase
Time frame: Through 24 to 72 hours corrective phase
Adverse events, serious adverse events, treatment-related adverse events, treatment-related serious adverse events and their incidences in subjects in the Maintenance phase
Time frame: Through 12-month Maintenance phase
Mean change from baseline in serum potassium at all time points of corrective phase
Time frame: Through 24 to 72 hours corrective phase
Exponential rate of change in serum potassium during the corrective phase
Time frame: Through 24 to 72 hours corrective phase
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Feb 2029, 28 months after the start.
Of 18 phase 3 interventional studies under Hyperkalemia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's planned 28 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: WS016
Waterstone Pharmaceutical (Wuhan) Co., LTD.