Actively Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study Evaluating WS016 for Treatment of Hyperkalemia
Led by Waterstone Pharmaceutical (Wuhan) Co., LTD. · Updated on 2025-11-26
420
Participants Needed
50
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug WS016 in adults with hyperkalemia, a condition characterized by elevated potassium levels in the blood. This Phase 3 clinical trial aims to study the effectiveness and safety of WS016 through a two-part design including a corrective phase to quickly reduce potassium levels and a maintenance phase to keep potassium normal. An open-label extension phase is also included to assess longer-term treatment effects. In Part A, participants are first randomized to receive either oral WS016 (12g) or placebo three times daily for 48 hours during the corrective phase. Those who achieve normal potassium levels are then re-randomized to receive WS016 at doses of 6g, 12g, or 18g, or placebo once daily for 28 days in the maintenance phase. Part B is an open-label extension lasting 11 months, where participants receive WS016 starting at 12g daily, with dose adjustments based on potassium levels. Participants will have regular blood tests to monitor serum potassium and other health measures throughout the study. Researchers will track potassium levels during the maintenance phase and corrective phase to assess drug effects. Safety and tolerability will be monitored, and participants completing or discontinuing the maintenance phase may continue treatment in the extension phase. Overall participation can last up to nearly a year depending on enrollment in Part B.
CONDITIONS
Brief 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 known allergy to WS016 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 disease causing language disorder, unresponsiveness, or severe limb movement blockage
- Recent myocardial infarction, cardiac intervention, or heart failure NYHA class IV within 3 months prior to screening
- Cardiac arrhythmia requiring urgent treatment or significant ECG abnormalities
- Prior major gastrointestinal surgery affecting normal gut 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 treatment
- Severe liver impairment with elevated liver enzymes more than 3 times normal
- Inability to complete the trial due to other diseases or psychiatric conditions or unfavorable risk-benefit assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days
Participants receive oral WS016 or placebo three times daily for 48 hours, totaling six doses, to correct serum potassium levels.
Daily visits during the 2-day treatment
Duration - 28 days
Participants whose serum potassium is normalized after corrective treatment receive oral WS016 or placebo once daily for 28 consecutive days to maintain potassium levels.
Regular visits during 28-day treatment
Duration - 11 months
Participants completing or discontinuing the maintenance phase who meet criteria receive oral WS016 once daily for 11 months with dose adjustments based on potassium levels.
Monthly visits during 11-month treatment
Trial Site Locations
Total: 50 locations
1
Investigator Site 02
Bengbu, Anhui, China, 233000
Actively Recruiting
2
Investigator Site 03
Wuhu, Anhui, China, 241000
Actively Recruiting
3
Investigator Site 48
Chongqing, Chongqing Municipality, China, 404100
Actively Recruiting
4
Investigator Site 04
Xiamen, Fujian, China, 361000
Actively Recruiting
5
Investigator Site 05
Lanzhou, Gansu, China, 730000
Actively Recruiting
6
Investigator Site 07
Guangzhou, Guangdong, China, 510000
Actively Recruiting
7
Investigator Site 06
Zhanjiang, Guangdong, China, 524000
Actively Recruiting
8
Investigator Site 08
Huizhou, Guangxi, China, 516000
Actively Recruiting
9
Investigator Site 09
Nanning, Guangxi, China, 530000
Actively Recruiting
10
Investigator Site 10
Nanning, Guangxi, China, 530000
Actively Recruiting
11
Investigator Site 11
Guiyang, Guizhou, China, 550000
Actively Recruiting
12
Investigator Site 12
Haikou, Hainan, China, 570100
Actively Recruiting
13
Investigator Site 13
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
14
Investigator Site 18
Daqing, Heilongjiang, China, 163000
Actively Recruiting
15
Investigator Site 15
Nanyang, Henan, China, 473000
Actively Recruiting
16
Investigator Site 16
Nanyang, Henan, China, 473000
Actively Recruiting
17
Investigator Site 14
Puyang, Henan, China, 457000
Actively Recruiting
18
Investigator Site 25
Xinxiang, Henan, China, 453000
Actively Recruiting
19
Investigator Site 21
Huangshi, Hubei, China, 435000
Actively Recruiting
20
Investigator Site 20
Shiyan, Hubei, China, 442000
Actively Recruiting
21
Investigator Site 19
Wuhan, Hubei, China, 430000
Actively Recruiting
22
Investigator Site 22
Wuhan, Hubei, China, 430000
Actively Recruiting
23
Investigator Site 24
Hengyang, Hunan, China, 421000
Actively Recruiting
24
Investigator Site 17
Yueyang, Hunan, China, 414000
Actively Recruiting
25
Investigator Site 23
Zhuzhou, Hunan, China, 412000
Actively Recruiting
26
Investigator Site 37
Chifeng, Inner Mongolia, China, 024000
Actively Recruiting
27
Investigator Site 36
Hohhot, Inner Mongolia, China, 010000
Actively Recruiting
28
Investigator Site 30
Changzhou, Jiangsu, China, 213000
Actively Recruiting
29
Investigator Site 31
Huai'an, Jiangsu, China, 223001
Actively Recruiting
30
Investigator Site 01
Nanjing, Jiangsu, China, 210000
Actively Recruiting
31
Investigator Site 26
Nantong, Jiangsu, China, 226000
Actively Recruiting
32
Investigator Site 27
Suzhou, Jiangsu, China, 215000
Actively Recruiting
33
Investigator Site 29
Yangzhou, Jiangsu, China, 225000
Actively Recruiting
34
Investigator Site 32
Ganzhou, Jiangxi, China, 341000
Actively Recruiting
35
Investigator Site 33
Nanchang, Jiangxi, China, 330000
Actively Recruiting
36
Investigator Site 34
Shangrao, Jiangxi, China, 334000
Actively Recruiting
37
Investigator Site 35
Shenyang, Liaoning, China, 110000
Actively Recruiting
38
Investigator Site 38
Yinchuan, Ningxia, China, 750000
Actively Recruiting
39
Investigator Site 42
Xi'an, Shaanxi, China, 710000
Actively Recruiting
40
Investigator Site 43
Xi'an, Shaanxi, China, 710000
Actively Recruiting
41
Investigator Site 41
Jinan, Shandong, China, 250000
Actively Recruiting
42
Investigator Site 40
Qingdao, Shandong, China, 266000
Actively Recruiting
43
Investigator Site 39
Tancheng, Shandong, China, 276100
Actively Recruiting
44
Investigator Site 44
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
45
Investigator Site 45
Chengdu, Sichuan, China, 610000
Actively Recruiting
46
Investigator Site 47
Chengdu, Sichuan, China, 610000
Actively Recruiting
47
Investigator Site 46
Deyang, Sichuan, China, 618000
Actively Recruiting
48
Investigator Site 49
Zigong, Sichuan, China, 643000
Actively Recruiting
49
Investigator Site 28
Jiaxing, Zhejiang, China, 314000
Actively Recruiting
50
Investigator Site 50
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
W
Waterstone Medical Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here