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RECRUITING
NCT07251309
PHASE3

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

Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2024-12-23

Completion Date

2026-11

Last Updated

2025-11-26

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (50)

Investigator Site 02

Bengbu, Anhui, China

Investigator Site 03

Wuhu, Anhui, China

Investigator Site 48

Chongqing, Chongqing Municipality, China

Investigator Site 04

Xiamen, Fujian, China

Investigator Site 05

Lanzhou, Gansu, China

Investigator Site 07

Guangzhou, Guangdong, China

Investigator Site 06

Zhanjiang, Guangdong, China

Investigator Site 08

Huizhou, Guangxi, China

Investigator Site 09

Nanning, Guangxi, China

Investigator Site 10

Nanning, Guangxi, China

Investigator Site 11

Guiyang, Guizhou, China

Investigator Site 12

Haikou, Hainan, China

Investigator Site 13

Shijiazhuang, Hebei, China

Investigator Site 18

Daqing, Heilongjiang, China

Investigator Site 15

Nanyang, Henan, China

Investigator Site 16

Nanyang, Henan, China

Investigator Site 14

Puyang, Henan, China

Investigator Site 25

Xinxiang, Henan, China

Investigator Site 21

Huangshi, Hubei, China

Investigator Site 20

Shiyan, Hubei, China

Investigator Site 19

Wuhan, Hubei, China

Investigator Site 22

Wuhan, Hubei, China

Investigator Site 24

Hengyang, Hunan, China

Investigator Site 17

Yueyang, Hunan, China

Investigator Site 23

Zhuzhou, Hunan, China

Investigator Site 37

Chifeng, Inner Mongolia, China

Investigator Site 36

Hohhot, Inner Mongolia, China

Investigator Site 30

Changzhou, Jiangsu, China

Investigator Site 31

Huai'an, Jiangsu, China

Investigator Site 01

Nanjing, Jiangsu, China

Investigator Site 26

Nantong, Jiangsu, China

Investigator Site 27

Suzhou, Jiangsu, China

Investigator Site 29

Yangzhou, Jiangsu, China

Investigator Site 32

Ganzhou, Jiangxi, China

Investigator Site 33

Nanchang, Jiangxi, China

Investigator Site 34

Shangrao, Jiangxi, China

Investigator Site 35

Shenyang, Liaoning, China

Investigator Site 38

Yinchuan, Ningxia, China

Investigator Site 42

Xi'an, Shaanxi, China

Investigator Site 43

Xi'an, Shaanxi, China

Investigator Site 41

Jinan, Shandong, China

Investigator Site 40

Qingdao, Shandong, China

Investigator Site 39

Tancheng, Shandong, China

Investigator Site 44

Shanghai, Shanghai Municipality, China

Investigator Site 45

Chengdu, Sichuan, China

Investigator Site 47

Chengdu, Sichuan, China

Investigator Site 46

Deyang, Sichuan, China

Investigator Site 49

Zigong, Sichuan, China

Investigator Site 28

Jiaxing, Zhejiang, China

Investigator Site 50

Wenzhou, Zhejiang, China