Evaluating WS016 for treating high potassium levels

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

This study tests if a new treatment called WS016 can safely help people with high potassium levels in their blood.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD. (Industry-sponsored)
• Locations: 26 sites (Beijing, Beijing and 25 other locations)
• Trial ID: NCT06277128 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of WS016 in patients with hyperkalemia. Participants will receive different doses of WS016 or a placebo during an acute treatment phase lasting 48 hours, followed by a maintenance phase of 12 days for those who achieve normokalemia. The study will involve approximately 140 participants who will be randomly assigned to treatment groups. The primary focus is to determine the effectiveness of WS016 in managing potassium levels in the blood.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with elevated potassium levels between 5.0 and 6.5 mmol/L.

Not a fit: Patients requiring immediate emergency treatment for hyperkalemia or those with pseudohyperkalemia will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing hyperkalemia.

How similar studies have performed: While there have been studies on hyperkalemia treatments, the specific approach with WS016 is novel and has not been extensively tested.

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.

Where this trial is running

Beijing, Beijing and 25 other locations

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

Study contacts

• Study coordinator: Waterstone Medical Center

Conditions Hyperkalemia