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New hope for high potassium: phase 3 drug trial launches

NCT ID NCT07251309

Disease control Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicine called WS016 for people with high potassium levels (hyperkalemia). The trial has two parts: a short phase to quickly lower potassium, followed by a month-long phase to keep it in a safe range. About 420 adults with moderately high potassium will take either WS016 or a placebo to see if the drug works safely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hyperkalemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperkalemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    50 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Investigator Site 01

    RECRUITING

    Nanjing, Jiangsu, 210000, China

  • Investigator Site 02

    RECRUITING

    Bengbu, Anhui, 233000, China

  • Investigator Site 03

    RECRUITING

    Wuhu, Anhui, 241000, China

  • Investigator Site 04

    RECRUITING

    Xiamen, Fujian, 361000, China

  • Investigator Site 05

    RECRUITING

    Lanzhou, Gansu, 730000, China

  • Investigator Site 06

    RECRUITING

    Zhanjiang, Guangdong, 524000, China

  • Investigator Site 07

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Investigator Site 08

    RECRUITING

    Huizhou, Guangxi, 516000, China

  • Investigator Site 09

    RECRUITING

    Nanning, Guangxi, 530000, China

  • Investigator Site 10

    RECRUITING

    Nanning, Guangxi, 530000, China

  • Investigator Site 11

    RECRUITING

    Guiyang, Guizhou, 550000, China

  • Investigator Site 12

    RECRUITING

    Haikou, Hainan, 570100, China

  • Investigator Site 13

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • Investigator Site 14

    RECRUITING

    Puyang, Henan, 457000, China

  • Investigator Site 15

    RECRUITING

    Nanyang, Henan, 473000, China

  • Investigator Site 16

    RECRUITING

    Nanyang, Henan, 473000, China

  • Investigator Site 17

    RECRUITING

    Yueyang, Hunan, 414000, China

  • Investigator Site 18

    RECRUITING

    Daqing, Heilongjiang, 163000, China

  • Investigator Site 19

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Investigator Site 20

    RECRUITING

    Shiyan, Hubei, 442000, China

  • Investigator Site 21

    RECRUITING

    Huangshi, Hubei, 435000, China

  • Investigator Site 22

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Investigator Site 23

    RECRUITING

    Zhuzhou, Hunan, 412000, China

  • Investigator Site 24

    RECRUITING

    Hengyang, Hunan, 421000, China

  • Investigator Site 25

    RECRUITING

    Xinxiang, Henan, 453000, China

  • Investigator Site 26

    RECRUITING

    Nantong, Jiangsu, 226000, China

  • Investigator Site 27

    RECRUITING

    Suzhou, Jiangsu, 215000, China

  • Investigator Site 28

    RECRUITING

    Jiaxing, Zhejiang, 314000, China

  • Investigator Site 29

    RECRUITING

    Yangzhou, Jiangsu, 225000, China

  • Investigator Site 30

    RECRUITING

    Changzhou, Jiangsu, 213000, China

  • Investigator Site 31

    RECRUITING

    Huai'an, Jiangsu, 223001, China

  • Investigator Site 32

    RECRUITING

    Ganzhou, Jiangxi, 341000, China

  • Investigator Site 33

    RECRUITING

    Nanchang, Jiangxi, 330000, China

  • Investigator Site 34

    RECRUITING

    Shangrao, Jiangxi, 334000, China

  • Investigator Site 35

    RECRUITING

    Shenyang, Liaoning, 110000, China

  • Investigator Site 36

    RECRUITING

    Hohhot, Inner Mongolia, 010000, China

  • Investigator Site 37

    RECRUITING

    Chifeng, Inner Mongolia, 024000, China

  • Investigator Site 38

    RECRUITING

    Yinchuan, Ningxia, 750000, China

  • Investigator Site 39

    RECRUITING

    Tancheng, Shandong, 276100, China

  • Investigator Site 40

    RECRUITING

    Qingdao, Shandong, 266000, China

  • Investigator Site 41

    RECRUITING

    Jinan, Shandong, 250000, China

  • Investigator Site 42

    RECRUITING

    Xi'an, Shaanxi, 710000, China

  • Investigator Site 43

    RECRUITING

    Xi'an, Shaanxi, 710000, China

  • Investigator Site 44

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Investigator Site 45

    RECRUITING

    Chengdu, Sichuan, 610000, China

  • Investigator Site 46

    RECRUITING

    Deyang, Sichuan, 618000, China

  • Investigator Site 47

    RECRUITING

    Chengdu, Sichuan, 610000, China

  • Investigator Site 48

    RECRUITING

    Chongqing, Chongqing Municipality, 404100, China

  • Investigator Site 49

    RECRUITING

    Zigong, Sichuan, 643000, China

  • Investigator Site 50

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

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