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

NCT07251309 | Recruiting Phase 3

• 1 other identifier: WS016CT301
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 50

Brief 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.

Conditions

Hyperkalemia

Outcome Measures

Primary Outcomes (1)

• Mean serum potassium level during maintenance phase Days 8-29

  Maintenance phase Days 8-29

Secondary Outcomes (5)

• Exponential rate of change in serum potassium during the corrective phase

  Through 48 hours corrective phase

• Mean change from baseline in serum potassium at all time points of corrective phase

  Through 48 hours corrective phase

• Cumulative duration (in days) of serum potassium within the normal range during the maintenance phase

  Maintenance phase baseline to maintenance phase Day 29

• Mean change from baseline in serum potassium at all time points of maintenance phase

  Through 28 days maintenance phase

• Percentage of participants with the mean serum potassium ≤5.0 mmol/L and percentage of participants with the mean serum potassium ≤5.5 mmol/L from D8 to D337 of the open-label extension phase

  Open-label extension phase Days 8-337

Study Arms (5)

WS016 (corrective phase)

EXPERIMENTAL

Drug: WS016

Placebo (corrective phase)

PLACEBO COMPARATOR

Drug: Placebo

WS016 (maintenance phase)

EXPERIMENTAL

Drug: WS016

Placebo (maintenance phase)

PLACEBO COMPARATOR

Drug: Placebo

WS016 (open-label extension phase)

EXPERIMENTAL

Drug: WS016

Interventions

WS016 DRUG

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

WS016 (corrective phase)

Placebo DRUG

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

Placebo (corrective phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Waterstone Pharmaceutical (Wuhan) Co., LTD.: lead

Study Sites (50)

Investigator Site 02

Bengbu, Anhui, 233000, China

RECRUITING

Investigator Site 03

Wuhu, Anhui, 241000, China

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Investigator Site 48

Chongqing, Chongqing Municipality, 404100, China

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Investigator Site 04

Xiamen, Fujian, 361000, China

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Investigator Site 05

Lanzhou, Gansu, 730000, China

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Investigator Site 07

Guangzhou, Guangdong, 510000, China

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Investigator Site 06

Zhanjiang, Guangdong, 524000, China

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Investigator Site 08

Huizhou, Guangxi, 516000, China

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Investigator Site 09

Nanning, Guangxi, 530000, China

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Investigator Site 10

Nanning, Guangxi, 530000, China

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Investigator Site 11

Guiyang, Guizhou, 550000, China

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Investigator Site 12

Haikou, Hainan, 570100, China

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Investigator Site 13

Shijiazhuang, Hebei, 050000, China

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Investigator Site 18

Daqing, Heilongjiang, 163000, China

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Investigator Site 15

Nanyang, Henan, 473000, China

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Investigator Site 16

Nanyang, Henan, 473000, China

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Investigator Site 14

Puyang, Henan, 457000, China

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Investigator Site 25

Xinxiang, Henan, 453000, China

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Investigator Site 21

Huangshi, Hubei, 435000, China

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Investigator Site 20

Shiyan, Hubei, 442000, China

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Investigator Site 19

Wuhan, Hubei, 430000, China

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Investigator Site 22

Wuhan, Hubei, 430000, China

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Investigator Site 24

Hengyang, Hunan, 421000, China

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Investigator Site 17

Yueyang, Hunan, 414000, China

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Investigator Site 23

Zhuzhou, Hunan, 412000, China

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Investigator Site 37

Chifeng, Inner Mongolia, 024000, China

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Investigator Site 36

Hohhot, Inner Mongolia, 010000, China

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Investigator Site 30

Changzhou, Jiangsu, 213000, China

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Investigator Site 31

Huai'an, Jiangsu, 223001, China

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Investigator Site 01

Nanjing, Jiangsu, 210000, China

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Investigator Site 26

Nantong, Jiangsu, 226000, China

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Investigator Site 27

Suzhou, Jiangsu, 215000, China

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Investigator Site 29

Yangzhou, Jiangsu, 225000, China

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Investigator Site 32

Ganzhou, Jiangxi, 341000, China

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Investigator Site 33

Nanchang, Jiangxi, 330000, China

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Investigator Site 34

Shangrao, Jiangxi, 334000, China

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Investigator Site 35

Shenyang, Liaoning, 110000, China

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Investigator Site 38

Yinchuan, Ningxia, 750000, China

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Investigator Site 42

Xi'an, Shaanxi, 710000, China

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Investigator Site 43

Xi'an, Shaanxi, 710000, China

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Investigator Site 41

Jinan, Shandong, 250000, China

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Investigator Site 40

Qingdao, Shandong, 266000, China

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Investigator Site 39

Tancheng, Shandong, 276100, China

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Investigator Site 44

Shanghai, Shanghai Municipality, 200000, China

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Investigator Site 45

Chengdu, Sichuan, 610000, China

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Investigator Site 47

Chengdu, Sichuan, 610000, China

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Investigator Site 46

Deyang, Sichuan, 618000, China

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Investigator Site 49

Zigong, Sichuan, 643000, China

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Investigator Site 28

Jiaxing, Zhejiang, 314000, China

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Investigator Site 50

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Waterstone Medical Center

CONTACT

+86 27 87531661; mpr2024_waterstone@waterstonepharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: December 23, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (50)