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A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD.
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
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