Abstract: TH-PO0396
Efficacy and Safety of WS016 in Patients with Hyperkalemia: Protocol for a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial
Session Information
- Fluid, Electrolyte, and Acid-Base Disorders: Clinical - 1
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Fluid, Electrolytes, and Acid-Base Disorders
- 1102 Fluid, Electrolyte, and Acid-Base Disorders: Clinical
Authors
- Zhang, Faming, WaterstonePharmaceutical (Wuhan) Co., LTD, Wuhan, China
- Yan, Fan, WaterstonePharmaceutical (Wuhan) Co., LTD, Wuhan, China
- Song, Aiyun, WaterstonePharmaceutical (Wuhan) Co., LTD, Wuhan, China
- Liu, Bi-Cheng, Zhongda Hospital Affiliated to Southeast University, Jiangsu, China
Group or Team Name
- WS016 Phase 3 China Study Group.
Background
A new potassium binder WS016, exchanging potassium with calcium and sodium in gut lumen, was demonstrated safety and efficacy in healthy volunteers and hyperkalemia patients. This protocol outlines a Phase 3 clinical trial designed to evaluate the efficacy and safety of WS016 in CKD patients with hyperkalemia.
Methods
This clinical trial consists of two parts: Part A which is the pivotal clinical trial and Part B which is the extension of part A.
Results
Part A is a multicenter, prospective, randomized, double-blind, placebo-controlled study in participants with hyperkalemia. It includes corrective phase (CP, 2 days) and maintenance phase (MP, 28 days). For CP, approximately 420 hyperkalemic patients were randomized into WS016 and placebo groups, receiving either WS016 (12 g) or placebo three times daily for 2 days to correct hyperkalemia. After CP, participants whose serum potassium levels return to the normal range (3.5–5.0 mmol/L, inclusive) are randomized to receive WS016 (6 g, 12 g, or 18 g) or placebo once daily for 28 days. The goal is to maintain normokalemia during the 28-day treatment period.
Part B is an open-label, 11-month extension study involving eligible participants from Part A who meet predefined inclusion criteria (3.5–6.0mmol/L, inclusive). Patients will receive WS016 at doses of 6 g, 12 g, or 18 g once daily, with dose adjustments permitted based on serum potassium levels at the investigators' discretion. The primary objective of Part A is to assess the efficacy of different WS016 doses in maintaining normokalemia over 28 days following initial correction which measured by the mean serum potassium level of each WS016 treatment group during MP Days 8-29, compared with placebo group. The second objective of partA is to assess the incidence of AEs and SAEs. The objective of part B is to assess the long-term safety and additional efficacy of WS016 over 11 months.
Conclusion
This trial will determine the effects of WS016 in managing hyperkalemia, particularly in chronic kidney disease (CKD) patients. The findings may provide new insights for optimizing hyperkalemia treatment strategies.
Trial registration: Chinese Clinical Trial Registry (ChiCTR20244172)
Funding
- Commercial Support – WaterstonePharmaceutical (Wuhan) Co., LTD, P.R. China