A Phase 3 test of WS016 for hyperkalemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, two-phase study in adults with hyperkalemia. In the corrective phase, participants receive WS016 three times daily for 24 to 72 hours to bring potassium into the normal range. Those who achieve normal potassium enter a 12-month maintenance phase with WS016, starting at 12 g daily and adjusting as needed to maintain potassium within the normal range. The study uses a dose-titration approach guided by serum potassium measurements. Safety monitoring is an ongoing component throughout both phases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults (male or female) aged 18 years and older;
* Participants with a serum potassium concentration \>5.0 mmol/L (serum potassium concentration will be measured using the i-STAT portable biochemical analyzer in screening period);
* Participants who have negative pregnancy test result at screening and ensure the use of contraception during the trial;
* Participants who understand and voluntarily sign the Informed Consent Form.

Exclusion Criteria:

* Participants who have a history of severe drug allergy, or are definitely allergic to the investigational product or its ingredients;
* Participants who have pseudohyperkalemia, such as serum potassium increasing caused by hemolysis of blood samples due to improper blood- Page 3 of 8 collection methods (such as too tight pressure pulse band banding, too heavy local rubbing, repeated fist clenching-loosening hands), hemolysis of blood samples due to difficulty in venipuncture or trauma, and severe leukocytosis (\>50 × 10\^9/L) or thrombocytosis (\>500 × 10\^9/L);
* Participants with acute hyperkalemia caused by conditions such as tumor lysis syndrome or hemolysis and so on;
* Participants suffering from severe cerebrovascular diseases, such as cerebral infarction or cerebral hemorrhagic disease, or those who may have language disorder or delayed responses due to a history of cerebrovascular disease and thus are unable to communicate normally during screening;
* Participants who have suffered from myocardial infarction, or have undergone interventional cardiac procedures or coronary artery bypass grafting for coronary atherosclerotic heart disease within 3 months prior to screening; or participants who have heart failure and are in cardiac function class IV (New York Heart Association, NYHA classification criteria) at screening;
* Patients with cardiac arrhythmia requiring urgent treatment at screening, such as ventricular tachycardia, ventricular fibrillation, II-III degree atrioventricular block, severe bradycardia (heart rate \<40 bpm), or patients with significant prolongation of PR interval (PR interval prolonged to more than 0.25 seconds in the absence of atrioventricular block), decrease or disappearance of P wave amplitude, and widening of QRS wave (widening to more than 0.14 seconds in the absence of bundle branch block) indicated by the electrocardiogram at screening;
* Patients who have previously undergone major gastrointestinal surgery such as subtotal gastrectomy, short bowel syndrome and other diseases affecting the normal peristalsis of the gastrointestinal tract; or patients with intractable constipation;
* Patients who have received treatment with polypropylene exchange resin or sodium zirconium cyclosilicate and other similar drugs within 3 days before screening;
* Patients who participated in other clinical trials of drugs or devices not approved for marketing within 3 months prior to the first dose;
* Participants who are receiving dialysis;
* Patients with severe hepatic impairment: serum alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal;
* Patients who are unable to complete this part of the trial as assessed by the investigator due to any other disease or psychiatric condition; or patients whose participation in the trial is assessed by the investigator as having a risk that far outweighs the benefit.

Where it's running

• Investigator Site 19
  Wuhu, Anhui, China Recruiting
• Investigator Site 50
  Beijing, Beijing Municipality, China Recruiting
• Investigator Site 22
  Guangzhou, Guangdong, China Recruiting
• Investigator Site 41
  Sanmenxia, Henan, China Recruiting
• Investigator Site 26
  Huangshi, Hubei, China Recruiting
• Investigator Site 24
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Waterstone Medical Center
• Email: mpr2024_waterstone@waterstonepharma.com
• Phone: +86 27 87531661

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Potassium-friendly plant-based diet for people with advanced CKD

  This pilot study tests whether a liberal plant-based diet with normal potassium levels is safe and acceptable for adults with advanced CKD (eGFR <30) who are not on dialysis.

  Recruiting Karolinska Institutet · Huddinge, Stockholm Län · NCT07494266

• Oral WS016 to quickly lower and maintain potassium in adults with hyperkalemia

  This trial tests whether oral WS016 can quickly lower high potassium and keep potassium in the normal range in adults with hyperkalemia.

  Recruiting at 50 sites Phase 3 Waterstone Pharmaceutical (Wuhan) Co., LTD. · Bengbu, Anhui and 49 other locations · NCT07251309

• How common high potassium is and what increases the risk in non-dialysis CKD patients in the community

  This project will test how common high potassium is and try to find which health and lifestyle factors raise the risk in adults with chronic kidney disease who are not on dialysis.

  Recruiting Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine · Shanghai, Shanghai Municipality · NCT06940414

• Adding urea to the final dialysis fluid

  This test tries adding urea to the dialysis fluid for adults with advanced kidney failure who have very high blood urea and need rapid lowering of potassium or correction of severe acidosis.

  Recruiting Phase 1/2 University of California, San Francisco · San Francisco, California · NCT06366230

• Using patiromer to improve blood pressure treatment in chronic kidney disease

  This study is testing if a medication called patiromer can help improve blood pressure treatment for people with chronic kidney disease by making another medication work better.

  Recruiting Phase 4 University Medical Center Groningen · Groningen · NCT06256991

• Using patiromer to treat high potassium levels in children under 12

  This study is testing if a medication called patiromer can safely help children under 12 with high potassium levels feel better.

  Recruiting at 32 sites Phase 2 Vifor Pharma · Aurora, Colorado and 36 other locations · NCT05766839

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.