Clinical trial NCT06277128: A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hyperkalemia
Lead sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD.
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase
timeFrame: Through the initial 48-hour acute treatment phase (from baseline to hour 48)
measure: Exponential rate of change in S-K levels during the maintenance treatment phase
timeFrame: Through 12 days of maintenance treatment phase (from Day 3 to Day 15)
Secondary outcomes:
measure: Mean change in S-K levels during the acute treatment phase
timeFrame: Through the initial 48-hour acute treatment phase
measure: Proportion of participants recover from hyperkalemia
timeFrame: Through the initial 48-hour acute treatment phase
measure: Time to normalization in S-K levels
timeFrame: Through the initial 48-hour acute treatment phase
measure: Proportion of patients remaining normokalemic
timeFrame: Day 15
measure: Mean change in S-K levels during the maintenance treatment phase
timeFrame: Through 12 days of maintenance treatment phase (from Day 3 to Day 15)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Xiamen
country: China
facility: Zhongshan Hospital, Xiamen University
state: Fujian
city: Baoding
country: China
facility: The Affiliated Hospital of Hebei University
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei Traditional Chinese Medicine Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Qiqihar
country: China
facility: The First Hospital of Qiqihar
state: Heilongjiang
city: Nanyang
country: China
facility: The First People's Hospital of Nanyang City
state: Henan
city: Puyang
country: China
facility: Puyang Oilfield General Hospital
state: Henan
city: Shiyan
country: China
facility: Shiyan Taihe Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan No.4 Hospital
state: Hubei
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
state: Hunan
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Sir Run Run Hospital, Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nantong
country: China
facility: The Affiliated Hospital of Nantong University
state: Jiangsu
city: Shenyang
country: China
facility: Shenyang Central Hospital, affiliated to Shenyang Medical College
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Linyi
country: China
facility: The First People's Hospital of Tancheng County
state: Shandong
city: Qingdao
country: China
facility: Qilu Hospital of Shandong University (Qingdao)
state: Shandong
city: Shanghai
country: China
facility: Minhang District Central Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai No.5 Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
city: Tianjin
country: China
facility: The Second Affiliated Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
Study officials:
References: