A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
NCT ID: NCT07251309
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
420 participants
INTERVENTIONAL
2024-12-23
2026-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia.
NCT06277128
The Safety and Tolerability of WS016 in Healthy Chinese Volunteers
NCT06281470
Safety of Oral Resin for Treatment of Hyperkalemia in Chinese Patients With Renal Insufficiency
NCT05462119
A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety and Treatment Pattern of Sodium Zirconium Cyclosilicate for Hyperkalaemia Management in Real World Practice in China
NCT05271266
To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension
NCT07191899
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After the 48-hour corrective treatment, participants whose serum potassium is within the normal range will be re-randomized in a 1:1:1:1 ratio to receive oral WS016 (6g, 12g, or 18g) or placebo once daily for 28 consecutive days.
Participants who complete the 28-day maintenance phase or prematurely discontinue from it due to hyperkalemia or hypokalemia, and who meet the eligibility criteria, will be eligible to enter Part B. In Part B, participants will receive WS016 for 11 months, starting at 12g once daily, with subsequent dose adjustments based on serum potassium levels.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
WS016 (corrective phase)
WS016
WS016 (12g), oral, three times daily for 48 hours, for a total of six doses.
Placebo (corrective phase)
Placebo
Placebo, oral, three times daily for 48 hours, for a total of six doses.
WS016 (maintenance phase)
WS016
WS016 (6g, 12g or 18g), oral, once daily for 28 consecutive days.
Placebo (maintenance phase)
Placebo
Placebo, oral, once daily for 28 consecutive days.
WS016 (open-label extension phase)
WS016
WS016, oral, once daily for 11 months, starting at a dose of 12g with subsequent dose adjustments based on serum potassium levels.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants with a serum potassium concentration \>5.0 mmol/L and ≤6.5 mmol/L (serum potassium concentration will be measured using the i-STAT portable biochemical analyzer in screening period);
* Participants who have negative pregnancy test result at screening and ensure the use of contraception during the trial;
* Participants who understand and voluntarily sign the Informed Consent Form.
Exclusion Criteria
* Participants who have pseudohyperkalemia, such as serum potassium increasing caused by hemolysis of blood samples due to improper blood collection methods (such as too tight pressure pulse band banding, too heavy local rubbing, repeated fist clenching-loosening hands), hemolysis of blood samples due to difficulty in venipuncture or trauma, and severe leukocytosis (\>50 × 10\^9/L) or thrombocytosis (\>500 × 10\^9/L);
* Participants with acute hyperkalemia caused by conditions such as tumor lysis syndrome or hemolysis and so on;
* Participants suffering from severe cerebrovascular diseases, such as cerebral infarction or cerebral hemorrhagic disease, with language disorder or unresponsiveness, or severely blocked limb movement;
* Participants who have suffered from myocardial infarction, or have undergone interventional cardiac procedures or coronary artery bypass grafting for coronary atherosclerotic heart disease within 3 months prior to screening; or participants who have heart failure and are in cardiac function class IV (New York Heart Association, NYHA classification criteria) at screening;
* Participants with cardiac arrhythmia requiring urgent treatment at screening, such as ventricular tachycardia, ventricular fibrillation, II-III degree atrioventricular block, severe bradycardia (heart rate \<40 bpm), or participants with significant prolongation of PR interval (PR interval prolonged to more than 0.25 seconds in the absence of pre-existing atrioventricular block), decrease or disappearance of P wave amplitude, and widening of QRS wave (widening to more than 0.14 seconds in the absence of pre-existing bundle branch block) indicated by the electrocardiogram at screening;
* Participants who have previously undergone major gastrointestinal surgery such as subtotal gastrectomy, short bowel syndrome and other diseases affecting the normal peristalsis of the gastrointestinal tract; or participants with intractable constipation;
* Participants who have received treatment with polypropylene exchange resin or sodium zirconium cyclosilicate and other similar drugs within 3 days before screening;
* Participants who participated in other clinical trials of drugs or devices not approved for marketing within 3 months prior to the first dose;
* Participants who are receiving dialysis;
* Participants with severe hepatic impairment: serum alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal;
* Participants who are unable to complete this part of the trial as assessed by the investigator due to any other disease or psychiatric condition; or participants whose participation in the trial is assessed by the investigator as having a risk that far outweighs the benefit.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Waterstone Pharmaceutical (Wuhan) Co., LTD.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WS016CT301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.