RECRUITING
Phase 3
ClinicalTrials.gov
A Two-Part, Open-Label, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD. • ClinicalTrials.gov ID: NCT07881965
Registry updated: 2026-10-20
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This clinical trial is an open-label, consisting of 2 phases, corrective phase (CP) and a maintenance phase (MP). The corrective phase aims to correct hyperkalemia within 24 to 72 hours, the maintenance phase aims to maintain the serum potassium level of subjects in the normal range for 12-month extension study carried out in participants who come from the first phase and meet certain inclusion criteria.
Interventions
-
WS016
(Drug)
There is no other interventions in this clinical study.
Eligibility criteria
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.
Conditions
Hyperkalemia
Locations
- Investigator Site 20 — Anqing, Anhui, China
- Investigator Site 18 — Hefei, Anhui, China
- Investigator Site 19 — Wuhu, Anhui, China
- Investigator Site 42 — Xuancheng, Anhui, China
- Investigator Site 50 — Beijing, Beijing Municipality, China
- Investigator Site 44 — Xiamen, Fujian, China
- Investigator Site 45 — Lanzhou, Gansu, China
- Investigator Site 22 — Guangzhou, Guangdong, China
- Investigator Site 23 — Shantou, Guangdong, China
- Investigator Site 21 — Zhanjiang, Guangdong, China
- Investigator Site 35 — Guiyang, Guizhou, China
- Investigator Site 02 — Shijiazhuang, Hebei, China
- Investigator Site 03 — Shijiazhuang, Hebei, China
- Investigator Site 04 — Luoyang, Henan, China
- Investigator Site 06 — Nanyang, Henan, China
- Investigator Site 07 — Puyang, Henan, China
- Investigator Site 41 — Sanmenxia, Henan, China
- Investigator Site 05 — Xinxiang, Henan, China
- Investigator Site 26 — Huangshi, Hubei, China
- Investigator Site 48 — Jingzhou, Hubei, China
- Investigator Site 27 — Shiyan, Hubei, China
- Investigator Site 24 — Wuhan, Hubei, China
- Investigator Site 25 — Wuhan, Hubei, China
- Investigator Site 30 — Zhuzhou, Hunan, China
- Investigator Site 37 — Hohhot, Inner Mongolia, China
- Investigator Site 10 — Nanjing, Jiangsu, China
- Investigator Site 11 — Nanjing, Jiangsu, China
- Investigator Site 14 — Nantong, Jiangsu, China
- Investigator Site 12 — Suzhou, Jiangsu, China
- Investigator Site 13 — Yangzhou, Jiangsu, China
- Investigator Site 29 — Ganzhou, Jiangxi, China
- Investigator Site 28 — Nanchang, Jiangxi, China
- Investigator Site 49 — Pingxiang, Jiangxi, China
- Investigator Site 38 — Shenyang, Liaoning, China
- Investigator Site 36 — Yinchuan, Ningxia, China
- Investigator Site 39 — Tai’an, Shandong, China
- Investigator Site 08 — Tancheng, Shandong, China
- Investigator Site 40 — Weifang, Shandong, China
- Investigator Site 09 — Shanghai, Shanghai Municipality, China
- Investigator Site 47 — Shanghai, Shanghai Municipality, China
- Investigator Site 46 — Xi'an, Shannxi, China
- Investigator Site 43 — Taiyuan, Shanxi, China
- Investigator Site 31 — Chengdu, Sichuan, China
- Investigator Site 33 — Chengdu, Sichuan, China
- Investigator Site 33 — Deyang, Sichuan, China
- Investigator Site 34 — Yibin, Sichuan, China
- Investigator Site 15 — Jiaxing, Zhejiang, China
- Investigator Site 16 — Ningbo, Zhejiang, China
- Investigator Site 17 — Ningbo, Zhejiang, China
- Investigator Site 01 — Beijing, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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