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RECRUITING
NCT07881965
PHASE3

A 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 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.

Official title: A Multicenter, Open-label Phase IIIb Clinical Study to Evaluate the Long-term Safety and Efficacy of WS016 in Patients With Hyperkalemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-09-25

Completion Date

2029-03-30

Last Updated

2026-10-26

Healthy Volunteers

No

Conditions

Interventions

DRUG

WS016

There is no other interventions in this clinical study.

Locations (50)

Investigator Site 20

Anqing, Anhui, China

Investigator Site 18

Hefei, Anhui, China

Investigator Site 19

Wuhu, Anhui, China

Investigator Site 42

Xuancheng, Anhui, China

Investigator Site 50

Beijing, Beijing Municipality, China

Investigator Site 44

Xiamen, Fujian, China

Investigator Site 45

Lanzhou, Gansu, China

Investigator Site 22

Guangzhou, Guangdong, China

Investigator Site 23

Shantou, Guangdong, China

Investigator Site 21

Zhanjiang, Guangdong, China

Investigator Site 35

Guiyang, Guizhou, China

Investigator Site 02

Shijiazhuang, Hebei, China

Investigator Site 03

Shijiazhuang, Hebei, China

Investigator Site 04

Luoyang, Henan, China

Investigator Site 06

Nanyang, Henan, China

Investigator Site 07

Puyang, Henan, China

Investigator Site 41

Sanmenxia, Henan, China

Investigator Site 05

Xinxiang, Henan, China

Investigator Site 26

Huangshi, Hubei, China

Investigator Site 48

Jingzhou, Hubei, China

Investigator Site 27

Shiyan, Hubei, China

Investigator Site 24

Wuhan, Hubei, China

Investigator Site 25

Wuhan, Hubei, China

Investigator Site 30

Zhuzhou, Hunan, China

Investigator Site 37

Hohhot, Inner Mongolia, China

Investigator Site 10

Nanjing, Jiangsu, China

Investigator Site 11

Nanjing, Jiangsu, China

Investigator Site 14

Nantong, Jiangsu, China

Investigator Site 12

Suzhou, Jiangsu, China

Investigator Site 13

Yangzhou, Jiangsu, China

Investigator Site 29

Ganzhou, Jiangxi, China

Investigator Site 28

Nanchang, Jiangxi, China

Investigator Site 49

Pingxiang, Jiangxi, China

Investigator Site 38

Shenyang, Liaoning, China

Investigator Site 36

Yinchuan, Ningxia, China

Investigator Site 39

Tai’an, Shandong, China

Investigator Site 08

Tancheng, Shandong, China

Investigator Site 40

Weifang, Shandong, China

Investigator Site 09

Shanghai, Shanghai Municipality, China

Investigator Site 47

Shanghai, Shanghai Municipality, China

Investigator Site 46

Xi'an, Shannxi, China

Investigator Site 43

Taiyuan, Shanxi, China

Investigator Site 31

Chengdu, Sichuan, China

Investigator Site 33

Chengdu, Sichuan, China

Investigator Site 33

Deyang, Sichuan, China

Investigator Site 34

Yibin, Sichuan, China

Investigator Site 15

Jiaxing, Zhejiang, China

Investigator Site 16

Ningbo, Zhejiang, China

Investigator Site 17

Ningbo, Zhejiang, China

Investigator Site 01

Beijing, China