Phase
Condition
N/ATreatment
Matching Placebo
WS016 3g
WS016 6g
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged ≥18 years old, male or female;
- The average blood potassium value measured by i-STAT for 2 consecutive times atscreening is >5.0 mmol/L and ≤6.5 mmol/L (with an interval of 60±10 minutes betweenthe 2 measurements);
- Participants must provide informed consent for this trial, be able to maintain goodcommunication with the investigator and comply with various requirements of theclinical trial (planned visits, laboratory tests, and other trial procedures, etc.).
Exclusion
Exclusion Criteria:
- Pseudohyperkalemia, such as blood samples hemolysis caused by improper bloodcollection methods (e.g., tight tourniquet, excessive local massage, repeatedclenching of the hand and release), participants with severe leukocytosis (>50×10^9/L)or thrombocytosis (>500×10^9/L);
- Participants with hyperkalemia who require emergency treatment according toinvestigators assessment: e.g., with significant abnormalities on electrocardiogram (ECG) (e.g., flattened or absent P wave, widened QRS complex), or neuromuscular systemsymptoms;
- Participants with symptomatic or uncontrolled atrial fibrillation, or asymptomaticpersistent ventricular tachycardia (participants with controlled atrial fibrillationafter drug treatment may be allowed to participate after assessment by theinvestigator);
- Type 1 diabetes mellitus, or participants who developed diabetic ketoacidosis within 1month before screening;
- Participants with severe swallowing dysfunction, moderate to severe gastrointestinaldysfunction, or major gastrointestinal surgery (e.g., bariatric surgery or colectomy);
- Participants who are receiving maintenance hemodialysis or peritoneal dialysis;
- Participants who received sodium polystyrene sulfonate, calcium polystyrene sulfonate,patiromer sorbitex calcium, or sodium zirconium cyclosilicate within 3 days before thefirst administration of the study drug;
- Participants who have undergone coronary artery bypass grafting, percutaneousinterventional therapy (such as heart, cerebrovascular, aortic) or major surgeriesincluding thoracic and cardiac surgery within 3 months prior to screening or areexpected to undergo these procedures during the study period;
- Participants who were hospitalized due to acute exacerbation of heart failure within 3months before screening.
- Participants who have undergone or are expected to undergo heart or kidneytransplantation during the study period;
- Participants with malignancies who are receiving antineoplastic treatment, or haveuncontrolled systemic diseases or mental illnesses, and are evaluated by theinvestigators not suitable for participation in this study;
- Participants with a life expectancy of less than 3 months;
- Participants who test positive for HIV antibodies, syphilis antibodies, hepatitis Cvirus (HCV) antibodies, or hepatitis B surface antigen (HBsAg) with serum hepatitis Bvirus (HBV) -DNA ≥2000 IU/mL (only in HBeAg-positive patients) at screening;
- Pregnant or breastfeeding women, or female participants who have had unprotectedsexual intercourse within the past two weeks, or female participants who test positivefor pregnancy; participants (or their partners) who have plans to conceive or donatesperm/ovum during the entire study period and 6 months after study completion, and areunwilling to use one or more contraceptive measures during the study period and 6months after study completion.
- Participants with any factors that are evaluated by the investigator, may affect theparticipant's ability to provide informed consent or comply with the study protocol,or may affect the trial results or participant safety.
Study Design
Study Description
Connect with a study center
Peking University People's Hospital
Beijing, Beijing 100000
ChinaActive - Recruiting
Peking University Shougang Hospital
Beijing, Beijing 100000
ChinaActive - Recruiting
Zhongshan Hospital, Xiamen University
Xiamen, Fujian 361000
ChinaActive - Recruiting
The Affiliated Hospital of Hebei University
Baoding, Hebei 071000
ChinaActive - Recruiting
Hebei Traditional Chinese Medicine Hospital
Shijiazhuang, Hebei 050000
ChinaActive - Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei 050000
ChinaActive - Recruiting
The First Hospital of Qiqihar
Qiqihar, Heilongjiang 161000
ChinaActive - Recruiting
The First People's Hospital of Nanyang City
Nanyang, Henan 473000
ChinaActive - Recruiting
Puyang Oilfield General Hospital
Puyang, Henan 457000
ChinaActive - Recruiting
Shiyan Taihe Hospital
Shiyan, Hubei 442000
ChinaActive - Recruiting
Wuhan No.4 Hospital
Wuhan, Hubei 430000
ChinaActive - Recruiting
Zhuzhou Central Hospital
Zhuzhou, Hunan 412000
ChinaActive - Recruiting
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia 010000
ChinaActive - Recruiting
Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu 210000
ChinaActive - Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu 210000
ChinaActive - Recruiting
The Affiliated Hospital of Nantong University
Nantong, Jiangsu 226000
ChinaActive - Recruiting
Shenyang Central Hospital, affiliated to Shenyang Medical College
Shenyang, Liaoning 110000
ChinaActive - Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia 750000
ChinaActive - Recruiting
The First People's Hospital of Tancheng County
Linyi, Shandong 276100
ChinaActive - Recruiting
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong 266000
ChinaActive - Recruiting
Minhang District Central Hospital
Shanghai, Shanghai 200000
ChinaActive - Recruiting
Shanghai First People's Hospital
Shanghai, Shanghai 200000
ChinaActive - Recruiting
Shanghai No.5 Hospital
Shanghai, Shanghai 200000
ChinaActive - Recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai 200000
ChinaActive - Recruiting
The Second Affiliated Hospital of Tianjin Medical University
Tianjin, Tianjin 300000
ChinaActive - Recruiting
Tianjin People's Hospital
Tianjin, Tianjin 300000
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.