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Clinical Trials in China / NCT07251309
Recruiting Phase 3

A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia

NCT07251309 · tracked via the Priya Life Science China tracker
Sponsor
Waterstone Pharmaceutical (Wuhan) Co., LTD.
Phase
Phase 3
Started
2024-12-23
Last updated
2025-11-26

Condition(s) studied

Hyperkalemia

Investigational drug(s) / intervention(s)

WS016PlaceboWS016PlaceboWS016

WS016: WS016 (12g), oral, three times daily for 48 hours, for a total of six doses.

Placebo: Placebo, oral, three times daily for 48 hours, for a total of six doses.

WS016: WS016 (6g, 12g or 18g), oral, once daily for 28 consecutive days.

Placebo: Placebo, oral, once daily for 28 consecutive days.

WS016: WS016, oral, once daily for 11 months, starting at a dose of 12g with subsequent dose adjustments based on serum potassium levels.

Study summary

This clinical trial consists of 2 parts, Part A and Part B. Part A consists of a 2-day randomized, double-blind, placebo-controlled corrective phase (CP) and a 28-day randomized, double-blind, placebo-controlled maintenance phase (MP). Part B (open-label extension, OLE) is an open-label, 11-month extension study carried out in participants who come from Part A and meet certain inclusion criteria.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Investigator Site 02 Bengbu Anhui Recruiting
Investigator Site 03 Wuhu Anhui Recruiting
Investigator Site 48 Chongqing Chongqing Municipality Recruiting
Investigator Site 04 Xiamen Fujian Recruiting
Investigator Site 05 Lanzhou Gansu Recruiting
Investigator Site 07 Guangzhou Guangdong Recruiting
Investigator Site 06 Zhanjiang Guangdong Recruiting
Investigator Site 08 Huizhou Guangxi Recruiting
Investigator Site 09 Nanning Guangxi Recruiting
Investigator Site 10 Nanning Guangxi Recruiting
Investigator Site 11 Guiyang Guizhou Recruiting
Investigator Site 12 Haikou Hainan Recruiting
Investigator Site 13 Shijiazhuang Hebei Recruiting
Investigator Site 18 Daqing Heilongjiang Recruiting
Investigator Site 15 Nanyang Henan Recruiting
Investigator Site 16 Nanyang Henan Recruiting
Investigator Site 14 Puyang Henan Recruiting
Investigator Site 25 Xinxiang Henan Recruiting
Investigator Site 21 Huangshi Hubei Recruiting
Investigator Site 20 Shiyan Hubei Recruiting
Investigator Site 19 Wuhan Hubei Recruiting
Investigator Site 22 Wuhan Hubei Recruiting
Investigator Site 24 Hengyang Hunan Recruiting
Investigator Site 17 Yueyang Hunan Recruiting
Investigator Site 23 Zhuzhou Hunan Recruiting
Investigator Site 37 Chifeng Inner Mongolia Recruiting
Investigator Site 36 Hohhot Inner Mongolia Recruiting
Investigator Site 30 Changzhou Jiangsu Recruiting
Investigator Site 31 Huai'an Jiangsu Recruiting
Investigator Site 01 Nanjing Jiangsu Recruiting
Investigator Site 26 Nantong Jiangsu Recruiting
Investigator Site 27 Suzhou Jiangsu Recruiting
Investigator Site 29 Yangzhou Jiangsu Recruiting
Investigator Site 32 Ganzhou Jiangxi Recruiting
Investigator Site 33 Nanchang Jiangxi Recruiting
Investigator Site 34 Shangrao Jiangxi Recruiting
Investigator Site 35 Shenyang Liaoning Recruiting
Investigator Site 38 Yinchuan Ningxia Recruiting
Investigator Site 42 Xi'an Shaanxi Recruiting
Investigator Site 43 Xi'an Shaanxi Recruiting

+ 10 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07251309 on ClinicalTrials.gov ↗ ← All trials in China