NCT07251309

A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of WS016 in Patients With Hyperkalemia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	WS016	WS016 (12g), oral, three times daily for 48 hours, for a total of six doses.
DRUG	Placebo	Placebo, oral, three times daily for 48 hours, for a total of six doses.
DRUG	WS016	WS016 (6g, 12g or 18g), oral, once daily for 28 consecutive days.
DRUG	Placebo	Placebo, oral, once daily for 28 consecutive days.
DRUG	WS016	WS016, oral, once daily for 11 months, starting at a dose of 12g with subsequent dose adjustments based on serum potassium levels.

Timeline

• Start date: 2024-12-23
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

50 sites across 1 country: China