A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia.

February 17, 2024 updated by: Waterstone Pharmaceutical (Wuhan) Co., LTD.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Peking University Shougang Hospital
        • Contact:
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • Zhongshan Hospital, Xiamen University
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 071000
        • Recruiting
        • The Affiliated Hospital of Hebei University
        • Contact:
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • Hebei Traditional Chinese Medicine Hospital
        • Contact:
    • Heilongjiang
      • Qiqihar, Heilongjiang, China, 161000
        • Recruiting
        • The First Hospital of Qiqihar
        • Contact:
    • Henan
      • Nanyang, Henan, China, 473000
        • Recruiting
        • The First People's Hospital of Nanyang City
        • Contact:
      • Puyang, Henan, China, 457000
        • Recruiting
        • Puyang Oilfield General Hospital
        • Contact:
    • Hubei
      • Shiyan, Hubei, China, 442000
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Wuhan No.4 Hospital
        • Contact:
    • Hunan
      • Zhuzhou, Hunan, China, 412000
        • Recruiting
        • ZhuZhou Central Hospital
        • Contact:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010000
        • Recruiting
        • Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Sir Run Run Hospital, Nanjing Medical University
        • Contact:
      • Nantong, Jiangsu, China, 226000
        • Recruiting
        • The Affiliated Hospital of Nantong University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Shenyang Central Hospital, affiliated to Shenyang Medical College
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750000
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
    • Shandong
      • Linyi, Shandong, China, 276100
        • Recruiting
        • The First People's Hospital of Tancheng County
        • Contact:
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • Qilu Hospital of Shandong University (QingDao)
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai First People's Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Minhang District Central Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai No.5 Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Tongji Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin People's Hospital
        • Contact:
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • The Second Affiliated Hospital of Tianjin Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥18 years old, male or female;
  2. 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);
  3. 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.).

Exclusion Criteria:

  1. 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);
  2. 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;
  3. 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);
  4. Type 1 diabetes mellitus, or participants who developed diabetic ketoacidosis within 1 month before screening;
  5. Participants with severe swallowing dysfunction, moderate to severe gastrointestinal dysfunction, or major gastrointestinal surgery (e.g., bariatric surgery or colectomy);
  6. Participants who are receiving maintenance hemodialysis or peritoneal dialysis;
  7. 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;
  8. 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;
  9. Participants who were hospitalized due to acute exacerbation of heart failure within 3 months before screening.
  10. Participants who have undergone or are expected to undergo heart or kidney transplantation during the study period;
  11. 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;
  12. Participants with a life expectancy of less than 3 months;
  13. 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;
  14. 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.
  15. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Matching Placebo
Drug: Matching Placebo
Acute treatment phase: Matching Placebo, oral, three times a day for 48 hours; Maintenance treatment phase: Matching Placebo, oral, once daily for 12 days.
Experimental: WS016 3g
Drug: WS016 3g
Acute treatment phase: WS016, oral, 3g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 3g, once daily for 12 days.
Experimental: WS016 6g
Drug: WS016 6g
Acute treatment phase: WS016, oral, 6g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 6g, once daily for 12 days.
Experimental: WS016 12g
Drug: WS016 12g
Acute treatment phase: WS016, oral, 12g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 12g, once daily for 12 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
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)
Through 12 days of maintenance treatment phase (from Day 3 to Day 15)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change in S-K levels during the acute treatment phase
Time Frame: Through the initial 48-hour acute treatment phase
The mean change in S-K levels during the acute treatment phase compared to baseline
Through the initial 48-hour acute treatment phase
Proportion of participants recover from hyperkalemia
Time Frame: Through the initial 48-hour acute treatment phase
The percentage of participants whose S-K levels return to normal during the acute treatment phase
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
The time(hours) it takes for participants' S-K levels to return to normal during the acute treatment phase
Through the initial 48-hour acute treatment phase
Proportion of patients remaining normokalemic
Time Frame: Day 15
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
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)
The mean change in S-K levels during the maintenance treatment phase compared to baseline
Through 12 days of maintenance treatment phase (from Day 3 to Day 15)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Waterstone Pharmaceutical (Wuhan) Co., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WS016-Ⅱ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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