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Tests treatment safety and results for Hyperkalemia
Official title A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
ClinicalTrials.gov ID: NCT07251309
What this study is testing
What is WS016?
WS016 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hyperkalemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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 likely can't join 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...
- 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...
- Participants who have suffered from myocardial infarction, or have undergone treatment cardiac procedures or coronary artery bypass grafting for...
- Participants with cardiac arrhythmia requiring urgent treatment at screening, such as ventricular tachycardia, ventricular fibrillation, II-III...
See the full eligibility 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.
- 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...
- 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 treatment cardiac procedures or coronary artery bypass grafting for coronary atherosclerotic heart disease within 3 months prior to 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 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 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Wuhu, Anhui, China
- Chongqing, Chongqing Municipality, China
- Xiamen, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Zhanjiang, Guangdong, China
- Huizhou, Guangxi, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Haikou, Hainan, China
- Shijiazhuang, Hebei, China
- Daqing, Heilongjiang, China
- Nanyang, Henan, China
- Puyang, Henan, China
- Xinxiang, Henan, China
- Huangshi, Hubei, China
- Shiyan, Hubei, China
- Wuhan, Hubei, China
- Hengyang, Hunan, China
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Wuhu, Anhui, China; Chongqing, Chongqing Municipality, China; Xiamen, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.