NCT06277128

A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia.

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Clinical Trial to Investigate the Efficacy and Safety of WS016 in the Patients With Hyperkalemia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	WS016 3g	Acute treatment phase: WS016, oral, 3g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 3g, once daily for 12 days.
DRUG	WS016 6g	Acute treatment phase: WS016, oral, 6g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 6g, once daily for 12 days.
DRUG	WS016 12g	Acute treatment phase: WS016, oral, 12g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 12g, once daily for 12 days.
DRUG	Matching Placebo	Acute treatment phase: Matching Placebo, oral, three times a day for 48 hours; Maintenance treatment phase: Matching Placebo, oral, once daily for 12 days.

Timeline

• Start date: 2023-09-11
• Primary completion: 2024-04-18
• Completion: 2024-08-04
• First posted: 2024-02-26
• Last updated: 2024-02-26

Locations

26 sites across 1 country: China