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

NCT06277128 | Recruiting Phase 2

• 1 other identifier: WS016-Ⅱ-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 26

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.

Conditions

Hyperkalemia

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Mean change in S-K levels during the acute treatment phase

  Through the initial 48-hour acute treatment phase

• Proportion of participants recover from hyperkalemia

  Through the initial 48-hour acute treatment phase

• Time to normalization in S-K levels

  Through the initial 48-hour acute treatment phase

• Proportion of patients remaining normokalemic

  Day 15

• Mean change in S-K levels during the maintenance treatment phase

  Through 12 days of maintenance treatment phase (from Day 3 to Day 15)

Study Arms (4)

WS016 3g

EXPERIMENTAL

Drug: WS016 3g

WS016 6g

EXPERIMENTAL

Drug: WS016 6g

WS016 12g

EXPERIMENTAL

Drug: WS016 12g

Matching Placebo

PLACEBO COMPARATOR

Drug: Matching Placebo

Interventions

WS016 3g DRUG

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 3g

WS016 6g DRUG

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 6g

WS016 12g DRUG

Acute treatment phase: WS016, oral, 12g , three times a day for 48 hours; Maintenance treatment phase: WS016, oral, 12g, once daily for 12 days.

WS016 12g

Matching Placebo DRUG

Acute treatment phase: Matching Placebo, oral, three times a day for 48 hours; Maintenance treatment phase: Matching Placebo, oral, once daily for 12 days.

Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years old, male or female;
• 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);
• 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.).

You may not qualify if:

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

Sponsors & Collaborators

• Waterstone Pharmaceutical (Wuhan) Co., LTD.: lead

Study Sites (26)

Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Zhongshan Hospital, Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

The Affiliated Hospital of Hebei University

Baoding, Hebei, 071000, China

RECRUITING

Hebei Traditional Chinese Medicine Hospital

Shijiazhuang, Hebei, 050000, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

The First Hospital of Qiqihar

Qiqihar, Heilongjiang, 161000, China

RECRUITING

The First People's Hospital of Nanyang City

Nanyang, Henan, 473000, China

RECRUITING

Puyang Oilfield General Hospital

Puyang, Henan, 457000, China

RECRUITING

Shiyan Taihe Hospital

Shiyan, Hubei, 442000, China

RECRUITING

Wuhan No.4 Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Zhuzhou Central Hospital

Zhuzhou, Hunan, 412000, China

RECRUITING

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010000, China

RECRUITING

Sir Run Run Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

RECRUITING

Shenyang Central Hospital, affiliated to Shenyang Medical College

Shenyang, Liaoning, 110000, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750000, China

RECRUITING

The First People's Hospital of Tancheng County

Linyi, Shandong, 276100, China

RECRUITING

Qilu Hospital of Shandong University (Qingdao)

Qingdao, Shandong, 266000, China

RECRUITING

Minhang District Central Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai No.5 Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

The Second Affiliated Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Waterstone Medical Center

CONTACT

+86 27+87531661; mpr2024_waterstone@waterstonepharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 26, 2024
• Study Start: September 11, 2023
• Primary Completion: April 18, 2024
• Study Completion: August 4, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

CN (26)