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A Two-Part, 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 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
WS016
WS016 (12g), oral, three times daily for 48 hours, for a total of six doses.
Placebo
Placebo, oral, three times daily for 48 hours, for a total of six doses.
WS016
WS016 (6g, 12g or 18g), oral, once daily for 28 consecutive days.
Placebo
Placebo, oral, once daily for 28 consecutive days.
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