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

Launched by WATERSTONE PHARMACEUTICAL (WUHAN) CO., LTD. · Feb 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called WS016 for people with hyperkalemia, which means they have high levels of potassium in their blood. The trial aims to find out if different doses of WS016 (3g, 6g, and 12g) given three times a day for 48 hours can effectively lower potassium levels compared to a placebo (a dummy treatment that has no active ingredients). After this initial treatment, researchers will see if taking WS016 once a day for 12 days can help keep potassium levels normal for those who have returned to a healthy range.

To be eligible for this trial, participants must be at least 18 years old and have a specific range of potassium levels in their blood. They should also be able to communicate well with the study team and follow the trial's requirements. However, people with certain health issues, like serious heart problems or those requiring emergency treatment for hyperkalemia, cannot participate. If you join the trial, you will be closely monitored, and your health and safety will be the top priority. This study is currently recruiting participants of all genders, and it offers a chance to help evaluate a potential new treatment for managing high potassium levels.

Gender

ALL

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.