HyperkalemiaPhase 2NCT06277128
A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia.
A Phase 2 study testing WS016 3g, WS016 6g and WS016 12g in people with Hyperkalemia, run by Waterstone Pharmaceutical (Wuhan) Co., LTD. at 26 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12… 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 3g, WS016 6g and WS016 12g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 26 sitesChina
- Study dates
- 11 Sep 2023to 4 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Aged ≥18 years old, male or female;
- The average blood potassium value measured by i-STAT for 2 consecutive times at screening is >5.0 mmol/L and ≤6.5 mmol/L (with an interval of 60±10 minutes between the 2 measurements);
- Participants must provide informed consent for this trial, be able to maintain good communication with the investigator and comply with various requirements of the clinical trial (planned visits, laboratory tests, and other trial procedures, etc.).
Who cannot join
- Pseudohyperkalemia, such as blood samples hemolysis caused by improper blood collection methods (e.g., tight tourniquet, excessive local massage, repeated clenching of the hand and release), participants with severe leukocytosis (>50×10^9/L) or thrombocytosis (>500×10^9/L);
- Participants with hyperkalemia who require emergency treatment according to investigators assessment: e.g., with significant abnormalities on electrocardiogram (ECG) (e.g., flattened or absent P wave, widened QRS complex), or neuromuscular system symptoms;
- Participants with symptomatic or uncontrolled atrial fibrillation, or asymptomatic persistent ventricular tachycardia (participants with controlled atrial fibrillation after drug treatment may be allowed to participate after assessment by the investigator);
- Type 1 diabetes mellitus, or participants who developed diabetic ketoacidosis within 1 month before screening;
- Participants with severe swallowing dysfunction, moderate to severe gastrointestinal dysfunction, or major gastrointestinal surgery (e.g., bariatric surgery or colectomy);
- Participants who are receiving maintenance hemodialysis or peritoneal dialysis;
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- Participants who received sodium polystyrene sulfonate, calcium polystyrene sulfonate, patiromer sorbitex calcium, or sodium zirconium cyclosilicate within 3 days before the first administration of the study drug;
- Participants who have undergone coronary artery bypass grafting, percutaneous interventional therapy (such as heart, cerebrovascular, aortic) or major surgeries including thoracic and cardiac surgery within 3 months prior to screening or are expected to undergo these procedures during the study period;
- Participants who were hospitalized due to acute exacerbation of heart failure within 3 months before screening.
- Participants who have undergone or are expected to undergo heart or kidney transplantation during the study period;
- Participants with malignancies who are receiving antineoplastic treatment, or have uncontrolled systemic diseases or mental illnesses, and are evaluated by the investigators not suitable for participation in this study;
- Participants with a life expectancy of less than 3 months;
- Participants who test positive for HIV antibodies, syphilis antibodies, hepatitis C virus (HCV) antibodies, or hepatitis B surface antigen (HBsAg) with serum hepatitis B virus (HBV) -DNA ≥2000 IU/mL (only in HBeAg-positive patients) at screening;
- Pregnant or breastfeeding women, or female participants who have had unprotected sexual intercourse within the past two weeks, or female participants who test positive for pregnancy; participants (or their partners) who have plans to conceive or donate sperm/ovum during the entire study period and 6 months after study completion, and are unwilling to use one or more contraceptive measures during the study period and 6 months after study completion.
- Participants with any factors that are evaluated by the investigator, may affect the participant's ability to provide informed consent or comply with the study protocol, or may affect the trial results or participant safety.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites, 26 recruiting
- Recruiting
The Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
Yan Gao, 86+ 13613125826, gaoyan227@sina.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100000
Li Zuo, 86+ 13910028495, zuoli@bjmu.edu.cn
- Recruiting
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100000
Zhenzhong Zhu, 86+ 13811830871, doczzz@sina.com
- Recruiting
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000
Jianrong Zhao, 86+ 13848129952, zjr13848129952@163.com
- Recruiting
The First People's Hospital of Tancheng County
Linyi, Shandong, 276100
Changyou Sun, 86+ 15168960721, scy6119125@126.com
- Recruiting
Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000
Wenwen Li, 86+ 13951644706, 546466035@qq.com
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Junwei Yang, 86+ 18951767513, jwyang@njmu.edu.cn
- Recruiting
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
Xinzhong Huang, 86+ 13912288751, huangxz421@126.com
- Recruiting
The First People's Hospital of Nanyang City
Nanyang, Henan, 473000
Mingai Song, 86+ 18937765862, ai13837706962@163.com
- Recruiting
Puyang Oilfield General Hospital
Puyang, Henan, 457000
Xianjun Xue, 86+ 13839288161, 13839288161@163.com
- Recruiting
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, 266000
Lanjie He, 86+ 18561812668, nxhelanjie@126.com
- Recruiting
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, 161000
Yanjun Zhao, 86+ 13945277125, 18603622020@126.com
- Recruiting
Minhang District Central Hospital
Shanghai, Shanghai Municipality, 200000
Xudong Xu, 86+ 18918169003, xxdmzx@sina.com
- Recruiting
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200000
Qiuling Fan, 86+ 13904012680, cmufql@163.com
- Recruiting
Shanghai No.5 Hospital
Shanghai, Shanghai Municipality, 200000
Jianying Niu, 86+ 18918168518, njyphd2008@163.com
- Recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200000
Chen Yu, 86+ 13311996821, yuchen@tongji.edu.cn
- Recruiting
Shenyang Central Hospital, affiliated to Shenyang Medical College
Shenyang, Liaoning, 110000
Zhenhua Ji, 86+ 18002477058, jzh642@sina.com
- Recruiting
Hebei Traditional Chinese Medicine Hospital
Shijiazhuang, Hebei, 050000
Jinchuan Tan, 86+ 13831187910, 1955981973@qq.com
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Shaomei Li, 86+ 15803210955, lishaomeitougao@126.com
- Recruiting
Shiyan Taihe Hospital
Shiyan, Hubei, 442000
Qinghong Zhang, 86+ 13971930628, zhangqinghong9809@126.com
- Recruiting
The Second Affiliated Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300000
Rong Li, 86+ 18698061623, beilloa@sohu.com
- Recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300000
Gang Long, 86+ 13602121007, longgang@hotmail.com
- Recruiting
Wuhan No.4 Hospital
Wuhan, Hubei, 430000
Chuanwen Xu, 86+ 18607171819, chuanwenxu@sina.com
- Recruiting
Zhongshan Hospital, Xiamen University
Xiamen, Fujian, 361000
Tianjun Guan, 86+ 13950199068, guantianjun@aliyun.com
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750000
Na Tian, 86+ 13995216063, 13995216063@163.com
- Recruiting
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412000
Qingfeng Peng, 86+ 13973319588, 460593067@qq.com
About this study
Official title: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Clinical Trial to Investigate the Efficacy and Safety of WS016 in the Patients With Hyperkalemia
The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase.
Read the detailed description
The study plan includes approximately 140 participants who will be randomly assigned to the WS016 and placebo treatment groups. Participants will begin a 48-hour acute treatment phase with three times-daily oral administrations. After the 48-hour acute treatment, participants have returned to normokalemia will be randomly assigned again to enter a 12-day maintenance treatment phase with once-daily oral administration.
- Conditions
- Hyperkalemia
- Being tested
- WS016 3g, WS016 6g, WS016 12g, Matching Placebo
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WS016 3gDrug
Acute treatment phase: WS016, oral, 3g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 3g, once daily for 12 days.
WS016 6gDrug
Acute treatment phase: WS016, oral, 6g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 6g, once daily for 12 days.
WS016 12gDrug
Acute treatment phase: WS016, oral, 12g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 12g, once daily for 12 days.
Matching PlaceboDrug
Acute treatment phase: Matching Placebo, oral, three times a day for 48 hours; Maintenance treatment phase: Matching Placebo, oral, once daily for 12 days.
| Study group | Role | What they receive |
|---|---|---|
| WS016 3g | Experimental | Not described Receives: Drug: WS016 3g |
| WS016 6g | Experimental | Not described Receives: Drug: WS016 6g |
| WS016 12g | Experimental | Not described Receives: Drug: WS016 12g |
| Matching Placebo | Placebo comparator | Not described Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase
Measured: Through the initial 48-hour acute treatment phase (from baseline to hour 48)
Exponential rate of change in S-K levels during the maintenance treatment phase
Measured: Through 12 days of maintenance treatment phase (from Day 3 to Day 15)
Secondary outcomes (5)
Mean change in S-K levels during the acute treatment phase
The mean change in S-K levels during the acute treatment phase compared to baseline
Measured: Through the initial 48-hour acute treatment phase
Proportion of participants recover from hyperkalemia
The percentage of participants whose S-K levels return to normal during the acute treatment phase
Measured: Through the initial 48-hour acute treatment phase
Time to normalization in S-K levels
The time(hours) it takes for participants' S-K levels to return to normal during the acute treatment phase
Measured: Through the initial 48-hour acute treatment phase
Proportion of patients remaining normokalemic
The percentage of participants whose S-K levels remain within the normal range (3.5-5.0 mmol/L) at the end of the maintenance treatment phase
Measured: Day 15
Mean change in S-K levels during the maintenance treatment phase
The mean change in S-K levels during the maintenance treatment phase compared to baseline
Measured: Through 12 days of maintenance treatment phase (from Day 3 to Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start11 Sep 2023
- Primary completion18 Apr 2024 (estimated)
- Study completion4 Aug 2024 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 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
- NCT06277128
- Sponsor's protocol ID
- WS016-Ⅱ-01
- Status last verified
- Feb 2024
- First submitted
- 3 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Clinical Trial to Investigate the Efficacy and Safety of WS016 in the Patients With Hyperkalemia
- ClinicalTrials.gov ID
- NCT06277128
- Acronym / sponsor ID
- WS016-Ⅱ-01
- Conditions
- Hyperkalemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Waterstone Pharmaceutical (Wuhan) Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 18 Apr 2024 (estimated)
- Study completion
- 4 Aug 2024 (estimated)
- First posted
- 26 Feb 2024 (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.
The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase.
Detailed description
The study plan includes approximately 140 participants who will be randomly assigned to the WS016 and placebo treatment groups. Participants will begin a 48-hour acute treatment phase with three times-daily oral administrations. After the 48-hour acute treatment, participants have returned to normokalemia will be randomly assigned again to enter a 12-day maintenance treatment phase with once-daily oral administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| WS016 3g | Experimental | Drug: WS016 3g |
| WS016 6g | Experimental | Drug: WS016 6g |
| WS016 12g | Experimental | Drug: WS016 12g |
| Matching Placebo | Placebo comparator | Drug: Matching Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥18 years old, male or female;
- The average blood potassium value measured by i-STAT for 2 consecutive times at screening is >5.0 mmol/L and ≤6.5 mmol/L (with an interval of 60±10 minutes between the 2 measurements);
- Participants must provide informed consent for this trial, be able to maintain good communication with the investigator and comply with various requirements of the clinical trial (planned visits, laboratory tests, and other trial procedures, etc.).
Key exclusion criteria (15 listed)
- Pseudohyperkalemia, such as blood samples hemolysis caused by improper blood collection methods (e.g., tight tourniquet, excessive local massage, repeated clenching of the hand and release), participants with severe leukocytosis (>50×10^9/L) or thrombocytosis (>500×10^9/L);
- Participants with hyperkalemia who require emergency treatment according to investigators assessment: e.g., with significant abnormalities on electrocardiogram (ECG) (e.g., flattened or absent P wave, widened QRS complex), or neuromuscular system symptoms;
- Participants with symptomatic or uncontrolled atrial fibrillation, or asymptomatic persistent ventricular tachycardia (participants with controlled atrial fibrillation after drug treatment may be allowed to participate after assessment by the investigator);
- Type 1 diabetes mellitus, or participants who developed diabetic ketoacidosis within 1 month before screening;
- Participants with severe swallowing dysfunction, moderate to severe gastrointestinal dysfunction, or major gastrointestinal surgery (e.g., bariatric surgery or colectomy);
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 |
|---|---|---|
| WS016 3gAcute treatment phase: WS016, oral, 3g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 3g, once daily for 12 days. | Drug | WS016 3g |
| WS016 6gAcute treatment phase: WS016, oral, 6g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 6g, once daily for 12 days. | Drug | WS016 6g |
| WS016 12gAcute treatment phase: WS016, oral, 12g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 12g, once daily for 12 days. | Drug | WS016 12g |
| Matching PlaceboAcute treatment phase: Matching Placebo, oral, three times a day for 48 hours; Maintenance treatment phase: Matching Placebo, oral, once daily for 12 days. | Drug | Matching Placebo |
Primary outcome
Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase
Time frame: Through the initial 48-hour acute treatment phase (from baseline to hour 48)
Exponential rate of change in S-K levels during the maintenance treatment phase
Time frame: Through 12 days of maintenance treatment phase (from Day 3 to Day 15)
5 secondary outcomes
Mean change in S-K levels during the acute treatment phase
Time frame: Through the initial 48-hour acute treatment phase
Proportion of participants recover from hyperkalemia
Time frame: Through the initial 48-hour acute treatment phase
Time to normalization in S-K levels
Time frame: Through the initial 48-hour acute treatment phase
Proportion of patients remaining normokalemic
Time frame: Day 15
Mean change in S-K levels during the maintenance treatment phase
Time frame: Through 12 days of maintenance treatment phase (from Day 3 to Day 15)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WS016 3g, WS016 6g and WS016 12g in people with Hyperkalemia, run by Waterstone Pharmaceutical (Wuhan) Co., LTD. at 26 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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase (time frame: Through the initial 48-hour acute treatment phase (from baseline to hour 48)). The study lists 2 primary outcomes in all. 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 Feb 2024.