HyperkalemiaPhase 3NCT07881965

A 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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This clinical trial is an open-label, consisting of 2 phases, corrective phase (CP) and a maintenance phase (MP). The corrective phase aims to correct hyperkalemia within 24 to 72 hours, the maintenance phase aims to maintain the serum potassium level of subjects in the normal range for 12-month extension study… 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 50 sitesChina
Study dates: 25 Sep 2026to 30 Mar 2029
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 (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- Page 3 of 8 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, or those who may have language disorder or delayed responses due to a history of cerebrovascular disease and thus are unable to communicate normally during screening;
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;
Patients 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 patients with significant prolongation of PR interval (PR interval prolonged to more than 0.25 seconds in the absence of 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 bundle branch block) indicated by the electrocardiogram at screening;

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Patients 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 patients with intractable constipation;
Patients who have received treatment with polypropylene exchange resin or sodium zirconium cyclosilicate and other similar drugs within 3 days before screening;
Patients 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;
Patients with severe hepatic impairment: serum alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal;
Patients who are unable to complete this part of the trial as assessed by the investigator due to any other disease or psychiatric condition; or patients 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.

Waterstone Medical Center contact

+86 27 87531661

mpr2024_waterstone@waterstonepharma.com

City, postcode or hospital

Sites recruiting now only

50 sites in 1 country

China50 sites, 50 recruiting

Investigator Site 20
Anqing, Anhui, 246000
Not yet recruiting
Investigator Site 50
Beijing, Beijing Municipality, 100000
Recruiting
Investigator Site 01
Beijing, 100000
Recruiting
Investigator Site 31
Chengdu, Sichuan, 610000
Not yet recruiting
Investigator Site 33
Chengdu, Sichuan, 610000
Not yet recruiting
Investigator Site 33
Deyang, Sichuan, 618000
Not yet recruiting
Investigator Site 29
Ganzhou, Jiangxi, 341000
Not yet recruiting
Investigator Site 22
Guangzhou, Guangdong, 510000
Recruiting
Investigator Site 35
Guiyang, Guizhou, 550000
Not yet recruiting
Investigator Site 18
Hefei, Anhui, 230000
Not yet recruiting
Investigator Site 37
Hohhot, Inner Mongolia, 010000
Not yet recruiting
Investigator Site 26
Huangshi, Hubei, 435000
Recruiting
Investigator Site 15
Jiaxing, Zhejiang, 314000
Not yet recruiting
Investigator Site 48
Jingzhou, Hubei, 434100
Not yet recruiting
Investigator Site 45
Lanzhou, Gansu, 730000
Not yet recruiting
Investigator Site 04
Luoyang, Henan, 471000
Not yet recruiting
Investigator Site 28
Nanchang, Jiangxi, 330000
Not yet recruiting
Investigator Site 10
Nanjing, Jiangsu, 210000
Recruiting
Investigator Site 11
Nanjing, Jiangsu, 210000
Recruiting
Investigator Site 14
Nantong, Jiangsu, 226000
Not yet recruiting
Investigator Site 06
Nanyang, Henan, 473000
Not yet recruiting
Investigator Site 16
Ningbo, Zhejiang, 315000
Not yet recruiting
Investigator Site 17
Ningbo, Zhejiang, 315010
Not yet recruiting
Investigator Site 49
Pingxiang, Jiangxi, 337000
Not yet recruiting
Investigator Site 07
Puyang, Henan, 457000
Not yet recruiting
Investigator Site 41
Sanmenxia, Henan, 472000
Recruiting
Investigator Site 09
Shanghai, Shanghai Municipality, 200000
Not yet recruiting
Investigator Site 47
Shanghai, Shanghai Municipality, 20000
Not yet recruiting
Investigator Site 23
Shantou, Guangdong, 515000
Not yet recruiting
Investigator Site 38
Shenyang, Liaoning, 110000
Recruiting
Investigator Site 02
Shijiazhuang, Hebei, 050000
Not yet recruiting
Investigator Site 03
Shijiazhuang, Hebei, 050000
Not yet recruiting
Investigator Site 27
Shiyan, Hubei, 442000
Not yet recruiting
Investigator Site 12
Suzhou, Jiangsu, 215000
Not yet recruiting
Investigator Site 39
Tai’an, Shandong, 271000
Not yet recruiting
Investigator Site 43
Taiyuan, Shanxi, 030000
Not yet recruiting
Investigator Site 08
Tancheng, Shandong, 276100
Recruiting
Investigator Site 40
Weifang, Shandong, 261000
Not yet recruiting
Investigator Site 24
Wuhan, Hubei, 430000
Recruiting
Investigator Site 25
Wuhan, Hubei, 430000
Not yet recruiting
Investigator Site 19
Wuhu, Anhui, 241000
Recruiting
Investigator Site 46
Xi'an, Shannxi, 710000
Not yet recruiting
Investigator Site 44
Xiamen, Fujian, 361000
Not yet recruiting
Investigator Site 05
Xinxiang, Henan, 453000
Not yet recruiting
Investigator Site 42
Xuancheng, Anhui, 242000
Not yet recruiting
Investigator Site 13
Yangzhou, Jiangsu, 225000
Not yet recruiting
Investigator Site 34
Yibin, Sichuan, 644000
Not yet recruiting
Investigator Site 36
Yinchuan, Ningxia, 750000
Not yet recruiting
Investigator Site 21
Zhanjiang, Guangdong, 524000
Not yet recruiting
Investigator Site 30
Zhuzhou, Hunan, 412000
Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-label Phase IIIb Clinical Study to Evaluate the Long-term Safety and Efficacy of WS016 in Patients With Hyperkalemia

Read the detailed description

Eligible participants with hyperkalemia will first receive oral WS016 (12g) three times daily, over 24 to 72 hours.

After the corrective treatment, participants whose serum potassium is within the normal range will be enter the open-label maintenance phase to receive WS016 for 12-month, starting at 12g once daily, with subsequent dose adjustments based on serum potassium levels.

Conditions: Hyperkalemia
Being tested: WS016
Medical subject headings: Hyperkalemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WS016Drug
There is no other interventions in this clinical study.

Study groups in NCT07881965
Study group	Role	What they receive
WS016	Experimental	Not described Receives: Drug: WS016

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of subjects with the mean serum potassium ≤5.0 mmol/L during maintenance phase
Measured: Maintenance phase 12-month

Secondary outcomes (4)

Adverse events, serious adverse events, treatment-related adverse events, treatment-related serious adverse events and their incidences in subjects in the corrective phase
Measured: Through 24 to 72 hours corrective phase
Adverse events, serious adverse events, treatment-related adverse events, treatment-related serious adverse events and their incidences in subjects in the Maintenance phase
Measured: Through 12-month Maintenance phase
Mean change from baseline in serum potassium at all time points of corrective phase
Measured: Through 24 to 72 hours corrective phase
Exponential rate of change in serum potassium during the corrective phase
Measured: Through 24 to 72 hours corrective phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 202630 Mar 2029

First posted20 Oct 2026
Study start25 Sep 2026
Primary completion20 Feb 2029 (estimated)
Study completion30 Mar 2029 (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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07881965
Sponsor's protocol ID: WS016-304
Status last verified: Oct 2026
First submitted: 13 Oct 2026
Last updated: 26 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Waterstone Medical Center

+86 27 87531661

mpr2024_waterstone@waterstonepharma.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
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
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
RecruitingPhase 2
Effect of Patiromer in Children Under 12 Years of Age With High Blood Potassium Levels
Hyperkalemia
RecruitingPhase 3
Keeping RAASi Treatment With Optimal Potassium Control
Chronic Kidney Diseases

All Hyperkalemia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label Phase IIIb Clinical Study to Evaluate the Long-term Safety and Efficacy of WS016 in Patients With Hyperkalemia
ClinicalTrials.gov ID: NCT07881965
Acronym / sponsor ID: WS016-304
Conditions: Hyperkalemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 300 participants (estimated)
Lead sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD.Industry (pharma, biotech, devices)
Study start: 25 Sep 2026 (actual)
Primary completion: 20 Feb 2029 (estimated)
Study completion: 30 Mar 2029 (estimated)
First posted: 20 Oct 2026 (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.

Detailed description

Eligible participants with hyperkalemia will first receive oral WS016 (12g) three times daily, over 24 to 72 hours.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
WS016	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 (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- Page 3 of 8 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, or those who may have language disorder or delayed responses due to a history of cerebrovascular disease and thus are unable to communicate normally during screening;
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
WS016There is no other interventions in this clinical study.	Drug	WS016

Primary outcome

Percentage of subjects with the mean serum potassium ≤5.0 mmol/L during maintenance phase
Time frame: Maintenance phase 12-month

4 secondary outcomes

Adverse events, serious adverse events, treatment-related adverse events, treatment-related serious adverse events and their incidences in subjects in the corrective phase
Time frame: Through 24 to 72 hours corrective phase
Adverse events, serious adverse events, treatment-related adverse events, treatment-related serious adverse events and their incidences in subjects in the Maintenance phase
Time frame: Through 12-month Maintenance phase
Mean change from baseline in serum potassium at all time points of corrective phase
Time frame: Through 24 to 72 hours corrective phase
Exponential rate of change in serum potassium during the corrective phase
Time frame: Through 24 to 72 hours corrective phase

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 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Hyperkalemia

Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
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
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
RecruitingPhase 2
Effect of Patiromer in Children Under 12 Years of Age With High Blood Potassium Levels
Hyperkalemia
RecruitingPhase 3
Keeping RAASi Treatment With Optimal Potassium Control
Chronic Kidney Diseases

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.

Waterstone Medical Center contact

+86 27 87531661

mpr2024_waterstone@waterstonepharma.com

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 Oct 2026. 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. 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?

Percentage of subjects with the mean serum potassium ≤5.0 mmol/L during maintenance phase (time frame: Maintenance phase 12-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07881965.

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 Oct 2026.