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A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Led by Waterstone Pharmaceutical (Wuhan) Co., LTD. · Updated on 2025-11-26
420
Participants Needed
50
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Serum potassium concentration greater than 5.0 mmol/L and less than or equal to 6.5 mmol/L
- Negative pregnancy test at screening and agreement to use contraception during the trial
- Ability to understand and voluntarily sign the informed consent form
You will not qualify if you...
- History of severe drug allergy or allergy to the investigational product or its ingredients
- Pseudohyperkalemia caused by blood sample hemolysis or severe leukocytosis or thrombocytosis
- Acute hyperkalemia caused by tumor lysis syndrome, hemolysis, or similar conditions
- Severe cerebrovascular diseases with language disorder, unresponsiveness, or severe limb movement issues
- Recent myocardial infarction or cardiac procedures within 3 months prior to screening
- Heart failure classified as NYHA class IV at screening
- Cardiac arrhythmias requiring urgent treatment, including ventricular tachycardia, ventricular fibrillation, severe bradycardia, or significant ECG abnormalities
- Previous major gastrointestinal surgery affecting normal bowel movement or intractable constipation
- Treatment with polypropylene exchange resin, sodium zirconium cyclosilicate, or similar drugs within 3 days before screening
- Participation in other clinical trials of unapproved drugs or devices within 3 months prior to first dose
- Receiving dialysis
- Severe liver impairment indicated by liver enzyme levels more than 3 times the upper limit of normal
- Inability to complete the trial due to other diseases or psychiatric conditions or if risks outweigh benefits according to the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 50 locations
1
Investigator Site 02
Bengbu, Anhui, China, 233000
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2
Investigator Site 03
Wuhu, Anhui, China, 241000
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3
Investigator Site 48
Chongqing, Chongqing Municipality, China, 404100
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4
Investigator Site 04
Xiamen, Fujian, China, 361000
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5
Investigator Site 05
Lanzhou, Gansu, China, 730000
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6
Investigator Site 07
Guangzhou, Guangdong, China, 510000
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7
Investigator Site 06
Zhanjiang, Guangdong, China, 524000
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8
Investigator Site 08
Huizhou, Guangxi, China, 516000
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9
Investigator Site 09
Nanning, Guangxi, China, 530000
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10
Investigator Site 10
Nanning, Guangxi, China, 530000
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11
Investigator Site 11
Guiyang, Guizhou, China, 550000
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12
Investigator Site 12
Haikou, Hainan, China, 570100
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13
Investigator Site 13
Shijiazhuang, Hebei, China, 050000
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14
Investigator Site 18
Daqing, Heilongjiang, China, 163000
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15
Investigator Site 15
Nanyang, Henan, China, 473000
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16
Investigator Site 16
Nanyang, Henan, China, 473000
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17
Investigator Site 14
Puyang, Henan, China, 457000
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18
Investigator Site 25
Xinxiang, Henan, China, 453000
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19
Investigator Site 21
Huangshi, Hubei, China, 435000
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20
Investigator Site 20
Shiyan, Hubei, China, 442000
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21
Investigator Site 19
Wuhan, Hubei, China, 430000
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22
Investigator Site 22
Wuhan, Hubei, China, 430000
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23
Investigator Site 24
Hengyang, Hunan, China, 421000
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24
Investigator Site 17
Yueyang, Hunan, China, 414000
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25
Investigator Site 23
Zhuzhou, Hunan, China, 412000
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26
Investigator Site 37
Chifeng, Inner Mongolia, China, 024000
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27
Investigator Site 36
Hohhot, Inner Mongolia, China, 010000
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28
Investigator Site 30
Changzhou, Jiangsu, China, 213000
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29
Investigator Site 31
Huai'an, Jiangsu, China, 223001
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30
Investigator Site 01
Nanjing, Jiangsu, China, 210000
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31
Investigator Site 26
Nantong, Jiangsu, China, 226000
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32
Investigator Site 27
Suzhou, Jiangsu, China, 215000
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33
Investigator Site 29
Yangzhou, Jiangsu, China, 225000
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34
Investigator Site 32
Ganzhou, Jiangxi, China, 341000
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35
Investigator Site 33
Nanchang, Jiangxi, China, 330000
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36
Investigator Site 34
Shangrao, Jiangxi, China, 334000
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37
Investigator Site 35
Shenyang, Liaoning, China, 110000
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38
Investigator Site 38
Yinchuan, Ningxia, China, 750000
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39
Investigator Site 42
Xi'an, Shaanxi, China, 710000
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40
Investigator Site 43
Xi'an, Shaanxi, China, 710000
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41
Investigator Site 41
Jinan, Shandong, China, 250000
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42
Investigator Site 40
Qingdao, Shandong, China, 266000
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43
Investigator Site 39
Tancheng, Shandong, China, 276100
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44
Investigator Site 44
Shanghai, Shanghai Municipality, China, 200000
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45
Investigator Site 45
Chengdu, Sichuan, China, 610000
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46
Investigator Site 47
Chengdu, Sichuan, China, 610000
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47
Investigator Site 46
Deyang, Sichuan, China, 618000
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48
Investigator Site 49
Zigong, Sichuan, China, 643000
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49
Investigator Site 28
Jiaxing, Zhejiang, China, 314000
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50
Investigator Site 50
Wenzhou, Zhejiang, China, 325000
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Research Team
W
Waterstone Medical Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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