HyperkalemiaPhase 3NCT07251309
A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
A Phase 3 study testing WS016 in people with Hyperkalemia, run by Waterstone Pharmaceutical (Wuhan) Co., LTD. at 50 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- WS016
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 50 sitesChina
- Study dates
- 23 Dec 2024to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (male or female) aged 18 years and older;
- 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.
Who cannot join
- Participants who have a history of severe drug allergy, or are definitely allergic to the investigational product or its ingredients;
- 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;
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- 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.
Trial locations and contacts
50 sites in 1 country. Contact the study team or a site near you to ask about taking part.
50 sites in 1 country
China50 sites, 50 recruiting
- Recruiting
Investigator Site 02
Bengbu, Anhui, 233000
- Recruiting
Investigator Site 30
Changzhou, Jiangsu, 213000
- Recruiting
Investigator Site 45
Chengdu, Sichuan, 610000
- Recruiting
Investigator Site 47
Chengdu, Sichuan, 610000
- Recruiting
Investigator Site 37
Chifeng, Inner Mongolia, 024000
- Recruiting
Investigator Site 48
Chongqing, Chongqing Municipality, 404100
- Recruiting
Investigator Site 18
Daqing, Heilongjiang, 163000
- Recruiting
Investigator Site 46
Deyang, Sichuan, 618000
- Recruiting
Investigator Site 32
Ganzhou, Jiangxi, 341000
- Recruiting
Investigator Site 07
Guangzhou, Guangdong, 510000
- Recruiting
Investigator Site 11
Guiyang, Guizhou, 550000
- Recruiting
Investigator Site 12
Haikou, Hainan, 570100
- Recruiting
Investigator Site 24
Hengyang, Hunan, 421000
- Recruiting
Investigator Site 36
Hohhot, Inner Mongolia, 010000
- Recruiting
Investigator Site 31
Huai'an, Jiangsu, 223001
- Recruiting
Investigator Site 21
Huangshi, Hubei, 435000
- Recruiting
Investigator Site 08
Huizhou, Guangxi, 516000
- Recruiting
Investigator Site 28
Jiaxing, Zhejiang, 314000
- Recruiting
Investigator Site 41
Jinan, Shandong, 250000
- Recruiting
Investigator Site 05
Lanzhou, Gansu, 730000
- Recruiting
Investigator Site 33
Nanchang, Jiangxi, 330000
- Recruiting
Investigator Site 01
Nanjing, Jiangsu, 210000
- Recruiting
Investigator Site 09
Nanning, Guangxi, 530000
- Recruiting
Investigator Site 10
Nanning, Guangxi, 530000
- Recruiting
Investigator Site 26
Nantong, Jiangsu, 226000
- Recruiting
Investigator Site 15
Nanyang, Henan, 473000
- Recruiting
Investigator Site 16
Nanyang, Henan, 473000
- Recruiting
Investigator Site 14
Puyang, Henan, 457000
- Recruiting
Investigator Site 40
Qingdao, Shandong, 266000
- Recruiting
Investigator Site 44
Shanghai, Shanghai Municipality, 200000
- Recruiting
Investigator Site 34
Shangrao, Jiangxi, 334000
- Recruiting
Investigator Site 35
Shenyang, Liaoning, 110000
- Recruiting
Investigator Site 13
Shijiazhuang, Hebei, 050000
- Recruiting
Investigator Site 20
Shiyan, Hubei, 442000
- Recruiting
Investigator Site 27
Suzhou, Jiangsu, 215000
- Recruiting
Investigator Site 39
Tancheng, Shandong, 276100
- Recruiting
Investigator Site 50
Wenzhou, Zhejiang, 325000
- Recruiting
Investigator Site 19
Wuhan, Hubei, 430000
- Recruiting
Investigator Site 22
Wuhan, Hubei, 430000
- Recruiting
Investigator Site 03
Wuhu, Anhui, 241000
- Recruiting
Investigator Site 42
Xi'an, Shaanxi, 710000
- Recruiting
Investigator Site 43
Xi'an, Shaanxi, 710000
- Recruiting
Investigator Site 04
Xiamen, Fujian, 361000
- Recruiting
Investigator Site 25
Xinxiang, Henan, 453000
- Recruiting
Investigator Site 29
Yangzhou, Jiangsu, 225000
- Recruiting
Investigator Site 38
Yinchuan, Ningxia, 750000
- Recruiting
Investigator Site 17
Yueyang, Hunan, 414000
- Recruiting
Investigator Site 06
Zhanjiang, Guangdong, 524000
- Recruiting
Investigator Site 23
Zhuzhou, Hunan, 412000
- Recruiting
Investigator Site 49
Zigong, Sichuan, 643000
About this study
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
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.
Read the detailed description
Eligible participants with hyperkalemia will first be randomized in a 5:1 ratio to receive oral WS016 (12g) or placebo three times daily, for a total of six doses over 48 hours.
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
- Hyperkalemia
- Being tested
- WS016, Placebo
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WS016Drug
WS016 (12g), oral, three times daily for 48 hours, for a total of six doses.
PlaceboDrug
Placebo, oral, three times daily for 48 hours, for a total of six doses.
WS016Drug
WS016 (6g, 12g or 18g), oral, once daily for 28 consecutive days.
PlaceboDrug
Placebo, oral, once daily for 28 consecutive days.
WS016Drug
WS016, oral, once daily for 11 months, starting at a dose of 12g with subsequent dose adjustments based on serum potassium levels.
| Study group | Role | What they receive |
|---|---|---|
| WS016 (corrective phase) | Experimental | Not described Receives: Drug: WS016 |
| Placebo (corrective phase) | Placebo comparator | Not described Receives: Drug: Placebo |
| WS016 (maintenance phase) | Experimental | Not described Receives: Drug: WS016 |
| Placebo (maintenance phase) | Placebo comparator | Not described Receives: Drug: Placebo |
| WS016 (open-label extension phase) | Experimental | Not described Receives: Drug: WS016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean serum potassium level during maintenance phase Days 8-29
Measured: Maintenance phase Days 8-29
Secondary outcomes (5)
Exponential rate of change in serum potassium during the corrective phase
Measured: Through 48 hours corrective phase
Mean change from baseline in serum potassium at all time points of corrective phase
Measured: Through 48 hours corrective phase
Cumulative duration (in days) of serum potassium within the normal range during the maintenance phase
Measured: Maintenance phase baseline to maintenance phase Day 29
Mean change from baseline in serum potassium at all time points of maintenance phase
Measured: Through 28 days maintenance phase
Percentage of participants with the mean serum potassium ≤5.0 mmol/L and percentage of participants with the mean serum potassium ≤5.5 mmol/L from D8 to D337 of the open-label extension phase
Measured: Open-label extension phase Days 8-337
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start23 Dec 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waterstone Pharmaceutical (Wuhan) Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251309
- Sponsor's protocol ID
- WS016CT301
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07251309
- Acronym / sponsor ID
- WS016CT301
- Conditions
- Hyperkalemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Waterstone Pharmaceutical (Wuhan) Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible participants with hyperkalemia will first be randomized in a 5:1 ratio to receive oral WS016 (12g) or placebo three times daily, for a total of six doses over 48 hours.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| WS016 (corrective phase) | Experimental | Drug: WS016 |
| Placebo (corrective phase) | Placebo comparator | Drug: Placebo |
| WS016 (maintenance phase) | Experimental | Drug: WS016 |
| Placebo (maintenance phase) | Placebo comparator | Drug: Placebo |
| WS016 (open-label extension phase) | Experimental | Drug: WS016 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (male or female) aged 18 years and older;
- 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.
Key exclusion criteria (12 listed)
- Participants who have a history of severe drug allergy, or are definitely allergic to the investigational product or its ingredients;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WS016WS016 (12g), oral, three times daily for 48 hours, for a total of six doses. | Drug | WS016 (corrective phase) |
| PlaceboPlacebo, oral, three times daily for 48 hours, for a total of six doses. | Drug | Placebo (corrective phase) |
| WS016WS016 (6g, 12g or 18g), oral, once daily for 28 consecutive days. | Drug | WS016 (maintenance phase) |
| PlaceboPlacebo, oral, once daily for 28 consecutive days. | Drug | Placebo (maintenance phase) |
| WS016WS016, oral, once daily for 11 months, starting at a dose of 12g with subsequent dose adjustments based on serum potassium levels. | Drug | WS016 (open-label extension phase) |
Primary outcome
Mean serum potassium level during maintenance phase Days 8-29
Time frame: Maintenance phase Days 8-29
5 secondary outcomes
Exponential rate of change in serum potassium during the corrective phase
Time frame: Through 48 hours corrective phase
Mean change from baseline in serum potassium at all time points of corrective phase
Time frame: Through 48 hours corrective phase
Cumulative duration (in days) of serum potassium within the normal range during the maintenance phase
Time frame: Maintenance phase baseline to maintenance phase Day 29
Mean change from baseline in serum potassium at all time points of maintenance phase
Time frame: Through 28 days maintenance phase
Percentage of participants with the mean serum potassium ≤5.0 mmol/L and percentage of participants with the mean serum potassium ≤5.5 mmol/L from D8 to D337 of the open-label extension phase
Time frame: Open-label extension phase Days 8-337
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Hyperkalemia
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Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WS016 in people with Hyperkalemia, run by Waterstone Pharmaceutical (Wuhan) Co., LTD. at 50 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Waterstone Medical Center (+86 27 87531661, mpr2024_waterstone@waterstonepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean serum potassium level during maintenance phase Days 8-29 (time frame: Maintenance phase Days 8-29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.