Oral WS016 to quickly lower and maintain potassium in adults with 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 two-part Phase 3 study begins with a 48-hour randomized, double-blind, placebo-controlled corrective phase in which eligible adults with serum potassium >5.0 to ≤6.5 mmol/L receive WS016 12 g or placebo three times daily for six doses. Participants whose potassium normalizes are re-randomized into a 28-day, double-blind maintenance phase to receive WS016 6 g, 12 g, 18 g, or placebo once daily. Those who complete or discontinue the maintenance phase for potassium abnormalities and meet criteria may enter an open-label 11-month extension starting at WS016 12 g once daily with dose adjustments based on potassium levels. Safety and serum potassium are monitored throughout to measure both rapid correction and longer-term control.

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 and ≤6.5 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 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, with language disorder or unresponsiveness, or severely blocked limb movement;
* 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;
* Participants 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 participants with significant prolongation of PR interval (PR interval prolonged to more than 0.25 seconds in the absence of pre-existing 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 pre-existing bundle branch block) indicated by the electrocardiogram at screening;
* Participants 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 participants with intractable constipation;
* Participants who have received treatment with polypropylene exchange resin or sodium zirconium cyclosilicate and other similar drugs within 3 days before screening;
* Participants 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;
* Participants with severe hepatic impairment: serum alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal;
* Participants who are unable to complete this part of the trial as assessed by the investigator due to any other disease or psychiatric condition; or participants 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 02
  Bengbu, Anhui, China Recruiting
• Investigator Site 03
  Wuhu, Anhui, China Recruiting
• Investigator Site 48
  Chongqing, Chongqing Municipality, China Recruiting
• Investigator Site 04
  Xiamen, Fujian, China Recruiting
• Investigator Site 05
  Lanzhou, Gansu, China Recruiting
• Investigator Site 07
  Guangzhou, Guangdong, 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.

• A Phase 3 test of WS016 for hyperkalemia

  This trial tests WS016 in adults with high potassium to see if it can quickly normalize levels and keep them steady for a year.

  Recruiting at 12 sites Phase 3 Waterstone Pharmaceutical (Wuhan) Co., LTD. · Anqing, Anhui and 49 other locations · NCT07881965

• 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

• 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.