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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of WS016 in Patients With Hyperkalemia

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

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD. (Industry-sponsored)
• Locations: 50 sites (Bengbu, Anhui and 49 other locations)
• Trial ID: NCT07251309 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 and older with confirmed serum potassium >5.0 and ≤6.5 mmol/L who can provide informed consent and meet contraception and safety requirements are ideal candidates.

Not a fit: Patients with pseudohyperkalemia, a known severe allergy to the investigational product or its ingredients, potassium outside the eligible range, pregnancy, or inability to attend study visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, WS016 could provide a fast, oral option to lower high potassium and help maintain normal levels, potentially reducing urgent care or dialysis needs.

How similar studies have performed: Similar oral potassium binders such as patiromer and sodium zirconium cyclosilicate have shown effectiveness for lowering potassium, so the approach has precedent though WS016 itself is being tested in Phase 3.

Eligibility criteria

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 this trial is running

Bengbu, Anhui and 49 other locations

• 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)
• Investigator Site 06 — Zhanjiang, Guangdong, China (Recruiting)
• Investigator Site 08 — Huizhou, Guangxi, China (Recruiting)
• Investigator Site 09 — Nanning, Guangxi, China (Recruiting)
• Investigator Site 10 — Nanning, Guangxi, China (Recruiting)
• Investigator Site 11 — Guiyang, Guizhou, China (Recruiting)
• Investigator Site 12 — Haikou, Hainan, China (Recruiting)
• Investigator Site 13 — Shijiazhuang, Hebei, China (Recruiting)
• Investigator Site 18 — Daqing, Heilongjiang, China (Recruiting)
• Investigator Site 15 — Nanyang, Henan, China (Recruiting)
• Investigator Site 16 — Nanyang, Henan, China (Recruiting)
• Investigator Site 14 — Puyang, Henan, China (Recruiting)
• Investigator Site 25 — Xinxiang, Henan, China (Recruiting)
• Investigator Site 21 — Huangshi, Hubei, China (Recruiting)
• Investigator Site 20 — Shiyan, Hubei, China (Recruiting)
• Investigator Site 19 — Wuhan, Hubei, China (Recruiting)
• Investigator Site 22 — Wuhan, Hubei, China (Recruiting)
• Investigator Site 24 — Hengyang, Hunan, China (Recruiting)
• Investigator Site 17 — Yueyang, Hunan, China (Recruiting)
• Investigator Site 23 — Zhuzhou, Hunan, China (Recruiting)
• Investigator Site 37 — Chifeng, Inner Mongolia, China (Recruiting)
• Investigator Site 36 — Hohhot, Inner Mongolia, China (Recruiting)
• Investigator Site 30 — Changzhou, Jiangsu, China (Recruiting)
• Investigator Site 31 — Huai'an, Jiangsu, China (Recruiting)
• Investigator Site 01 — Nanjing, Jiangsu, China (Recruiting)
• Investigator Site 26 — Nantong, Jiangsu, China (Recruiting)
• Investigator Site 27 — Suzhou, Jiangsu, China (Recruiting)
• Investigator Site 29 — Yangzhou, Jiangsu, China (Recruiting)
• Investigator Site 32 — Ganzhou, Jiangxi, China (Recruiting)
• Investigator Site 33 — Nanchang, Jiangxi, China (Recruiting)
• Investigator Site 34 — Shangrao, Jiangxi, China (Recruiting)
• Investigator Site 35 — Shenyang, Liaoning, China (Recruiting)
• Investigator Site 38 — Yinchuan, Ningxia, China (Recruiting)
• Investigator Site 42 — Xi'an, Shaanxi, China (Recruiting)
• Investigator Site 43 — Xi'an, Shaanxi, China (Recruiting)
• Investigator Site 41 — Jinan, Shandong, China (Recruiting)
• Investigator Site 40 — Qingdao, Shandong, China (Recruiting)
• Investigator Site 39 — Tancheng, Shandong, China (Recruiting)
• Investigator Site 44 — Shanghai, Shanghai Municipality, China (Recruiting)
• Investigator Site 45 — Chengdu, Sichuan, China (Recruiting)
• Investigator Site 47 — Chengdu, Sichuan, China (Recruiting)
• Investigator Site 46 — Deyang, Sichuan, China (Recruiting)
• Investigator Site 49 — Zigong, Sichuan, China (Recruiting)
• Investigator Site 28 — Jiaxing, Zhejiang, China (Recruiting)
• Investigator Site 50 — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Waterstone Medical Center

Conditions Hyperkalemia