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

Last updated: February 17, 2024
Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Matching Placebo

WS016 3g

WS016 6g

Clinical Study ID

NCT06277128
WS016-Ⅱ-01
  • Ages > 18
  • All Genders

Study 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 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged ≥18 years old, male or female;
  2. The average blood potassium value measured by i-STAT for 2 consecutive times atscreening is >5.0 mmol/L and ≤6.5 mmol/L (with an interval of 60±10 minutes betweenthe 2 measurements);
  3. Participants must provide informed consent for this trial, be able to maintain goodcommunication with the investigator and comply with various requirements of theclinical trial (planned visits, laboratory tests, and other trial procedures, etc.).

Exclusion

Exclusion Criteria:

  1. Pseudohyperkalemia, such as blood samples hemolysis caused by improper bloodcollection methods (e.g., tight tourniquet, excessive local massage, repeatedclenching 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 toinvestigators assessment: e.g., with significant abnormalities on electrocardiogram (ECG) (e.g., flattened or absent P wave, widened QRS complex), or neuromuscular systemsymptoms;
  3. Participants with symptomatic or uncontrolled atrial fibrillation, or asymptomaticpersistent ventricular tachycardia (participants with controlled atrial fibrillationafter drug treatment may be allowed to participate after assessment by theinvestigator);
  4. Type 1 diabetes mellitus, or participants who developed diabetic ketoacidosis within 1month before screening;
  5. Participants with severe swallowing dysfunction, moderate to severe gastrointestinaldysfunction, 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 thefirst administration of the study drug;
  8. Participants who have undergone coronary artery bypass grafting, percutaneousinterventional therapy (such as heart, cerebrovascular, aortic) or major surgeriesincluding thoracic and cardiac surgery within 3 months prior to screening or areexpected to undergo these procedures during the study period;
  9. Participants who were hospitalized due to acute exacerbation of heart failure within 3months before screening.
  10. Participants who have undergone or are expected to undergo heart or kidneytransplantation during the study period;
  11. Participants with malignancies who are receiving antineoplastic treatment, or haveuncontrolled systemic diseases or mental illnesses, and are evaluated by theinvestigators 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 Cvirus (HCV) antibodies, or hepatitis B surface antigen (HBsAg) with serum hepatitis Bvirus (HBV) -DNA ≥2000 IU/mL (only in HBeAg-positive patients) at screening;
  14. Pregnant or breastfeeding women, or female participants who have had unprotectedsexual intercourse within the past two weeks, or female participants who test positivefor pregnancy; participants (or their partners) who have plans to conceive or donatesperm/ovum during the entire study period and 6 months after study completion, and areunwilling to use one or more contraceptive measures during the study period and 6months after study completion.
  15. Participants with any factors that are evaluated by the investigator, may affect theparticipant's ability to provide informed consent or comply with the study protocol,or may affect the trial results or participant safety.

Study Design

Total Participants: 140
Treatment Group(s): 4
Primary Treatment: Matching Placebo
Phase: 2
Study Start date:
September 11, 2023
Estimated Completion Date:
August 04, 2024

Study 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.

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Peking University Shougang Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Zhongshan Hospital, Xiamen University

    Xiamen, Fujian 361000
    China

    Active - Recruiting

  • The Affiliated Hospital of Hebei University

    Baoding, Hebei 071000
    China

    Active - Recruiting

  • Hebei Traditional Chinese Medicine Hospital

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • The First Hospital of Qiqihar

    Qiqihar, Heilongjiang 161000
    China

    Active - Recruiting

  • The First People's Hospital of Nanyang City

    Nanyang, Henan 473000
    China

    Active - Recruiting

  • Puyang Oilfield General Hospital

    Puyang, Henan 457000
    China

    Active - Recruiting

  • Shiyan Taihe Hospital

    Shiyan, Hubei 442000
    China

    Active - Recruiting

  • Wuhan No.4 Hospital

    Wuhan, Hubei 430000
    China

    Active - Recruiting

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan 412000
    China

    Active - Recruiting

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 010000
    China

    Active - Recruiting

  • Sir Run Run Hospital, Nanjing Medical University

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

  • The Affiliated Hospital of Nantong University

    Nantong, Jiangsu 226000
    China

    Active - Recruiting

  • Shenyang Central Hospital, affiliated to Shenyang Medical College

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750000
    China

    Active - Recruiting

  • The First People's Hospital of Tancheng County

    Linyi, Shandong 276100
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University (Qingdao)

    Qingdao, Shandong 266000
    China

    Active - Recruiting

  • Minhang District Central Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • Shanghai First People's Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • Shanghai No.5 Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • Shanghai Tongji Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Tianjin Medical University

    Tianjin, Tianjin 300000
    China

    Active - Recruiting

  • Tianjin People's Hospital

    Tianjin, Tianjin 300000
    China

    Active - Recruiting

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