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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

140

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

September 11, 2023

Primary Completion (Estimated)

April 18, 2024

Study Completion (Estimated)

August 4, 2024

Study Registration Dates

First Submitted

February 3, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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