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

Hyperkalemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06277128
• Other study ID #: WS016-?-01
• Status: Recruiting
• Phase: Phase 2
• Start date: September 11, 2023
• Est. completion date: August 4, 2024

Study information

• Verified date: February 2024
• Source: Waterstone Pharmaceutical (Wuhan) Co., LTD.
• Contact: Waterstone Medical Center
• Phone: +86 27+87531661
• Email: mpr2024_waterstone[@]waterstonepharma.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 4, 2024
• Est. primary completion date: April 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperkalemia

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Hebei University	Baoding	Hebei
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing
China	Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	The First People's Hospital of Tancheng County	Linyi	Shandong
China	Sir Run Run Hospital, Nanjing Medical University	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	The Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	The First People's Hospital of Nanyang City	Nanyang	Henan
China	Puyang Oilfield General Hospital	Puyang	Henan
China	Qilu Hospital of Shandong University (Qingdao)	Qingdao	Shandong
China	The First Hospital of Qiqihar	Qiqihar	Heilongjiang
China	Minhang District Central Hospital	Shanghai	Shanghai
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	Shanghai No.5 Hospital	Shanghai	Shanghai
China	Shanghai Tongji Hospital	Shanghai	Shanghai
China	Shenyang Central Hospital, affiliated to Shenyang Medical College	Shenyang	Liaoning
China	Hebei Traditional Chinese Medicine Hospital	Shijiazhuang	Hebei
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Shiyan Taihe Hospital	Shiyan	Hubei
China	The Second Affiliated Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin People's Hospital	Tianjin	Tianjin
China	Wuhan No.4 Hospital	Wuhan	Hubei
China	Zhongshan Hospital, Xiamen University	Xiamen	Fujian
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Zhuzhou Central Hospital	Zhuzhou	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Waterstone Pharmaceutical (Wuhan) Co., LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase		Through the initial 48-hour acute treatment phase (from baseline to hour 48)
Primary	Exponential rate of change in S-K levels during the maintenance treatment phase		Through 12 days of maintenance treatment phase (from Day 3 to Day 15)
Secondary	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	Through the initial 48-hour acute treatment phase
Secondary	Proportion of participants recover from hyperkalemia	The percentage of participants whose S-K levels return to normal during the acute treatment phase	Through the initial 48-hour acute treatment phase
Secondary	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	Through the initial 48-hour acute treatment phase
Secondary	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	Day 15
Secondary	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	Through 12 days of maintenance treatment phase (from Day 3 to Day 15)