protocolSection identificationModule nctId: NCT06277128, orgStudyIdInfo id: WS016-Ⅱ-01, briefTitle: A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-11, primaryCompletionDateStruct date: 2024-04-18, completionDateStruct date: 2024-08-04, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Waterstone Pharmaceutical (Wuhan) Co., LTD., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase., conditionsModule conditions: Hyperkalemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: WS016 3g, interventions name: WS016 6g, interventions name: WS016 12g, interventions name: Matching Placebo, outcomesModule primaryOutcomes measure: Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase, primaryOutcomes measure: Exponential rate of change in S-K levels during the maintenance treatment phase, secondaryOutcomes measure: Mean change in S-K levels during the acute treatment phase, secondaryOutcomes measure: Proportion of participants recover from hyperkalemia, secondaryOutcomes measure: Time to normalization in S-K levels, secondaryOutcomes measure: Proportion of patients remaining normokalemic, secondaryOutcomes measure: Mean change in S-K levels during the maintenance treatment phase, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Li Zuo, role: CONTACT, phone: 86+ 13910028495, email: zuoli@bjmu.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Shougang Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Zhenzhong Zhu, role: CONTACT, phone: 86+ 13811830871, email: doczzz@sina.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Zhongshan Hospital, Xiamen University, status: RECRUITING, city: Xiamen, state: Fujian, zip: 361000, country: China, contacts name: Tianjun Guan, role: CONTACT, phone: 86+ 13950199068, email: guantianjun@aliyun.com, geoPoint lat: 24.47979, lon: 118.08187, locations facility: The Affiliated Hospital of Hebei University, status: RECRUITING, city: Baoding, state: Hebei, zip: 071000, country: China, contacts name: Yan Gao, role: CONTACT, phone: 86+ 13613125826, email: gaoyan227@sina.com, geoPoint lat: 38.85111, lon: 115.49028, locations facility: Hebei Traditional Chinese Medicine Hospital, status: RECRUITING, city: Shijiazhuang, state: Hebei, zip: 050000, country: China, contacts name: Jinchuan Tan, role: CONTACT, phone: 86+ 13831187910, email: 1955981973@qq.com, geoPoint lat: 38.04139, lon: 114.47861, locations facility: The Second Hospital of Hebei Medical University, status: RECRUITING, city: Shijiazhuang, state: Hebei, zip: 050000, country: China, contacts name: Shaomei Li, role: CONTACT, phone: 86+ 15803210955, email: lishaomeitougao@126.com, geoPoint lat: 38.04139, lon: 114.47861, locations facility: The First Hospital of Qiqihar, status: RECRUITING, city: Qiqihar, state: Heilongjiang, zip: 161000, country: China, contacts name: Yanjun Zhao, role: CONTACT, phone: 86+ 13945277125, email: 18603622020@126.com, geoPoint lat: 47.34088, lon: 123.96045, locations facility: The First People's Hospital of Nanyang City, status: RECRUITING, city: Nanyang, state: Henan, zip: 473000, country: China, contacts name: Mingai Song, role: CONTACT, phone: 86+ 18937765862, email: ai13837706962@163.com, geoPoint lat: 32.99472, lon: 112.53278, locations facility: Puyang Oilfield General Hospital, status: RECRUITING, city: Puyang, state: Henan, zip: 457000, country: China, contacts name: Xianjun Xue, role: CONTACT, phone: 86+ 13839288161, email: 13839288161@163.com, geoPoint lat: 29.45679, lon: 119.88872, locations facility: Shiyan Taihe Hospital, status: RECRUITING, city: Shiyan, state: Hubei, zip: 442000, country: China, contacts name: Qinghong Zhang, role: CONTACT, phone: 86+ 13971930628, email: zhangqinghong9809@126.com, geoPoint lat: 32.6475, lon: 110.77806, locations facility: Wuhan No.4 Hospital, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Chuanwen Xu, role: CONTACT, phone: 86+ 18607171819, email: chuanwenxu@sina.com, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Zhuzhou Central Hospital, status: RECRUITING, city: Zhuzhou, state: Hunan, zip: 412000, country: China, contacts name: Qingfeng Peng, role: CONTACT, phone: 86+ 13973319588, email: 460593067@qq.com, geoPoint lat: 27.83333, lon: 113.15, locations facility: Affiliated Hospital of Inner Mongolia Medical University, status: RECRUITING, city: Hohhot, state: Inner Mongolia, zip: 010000, country: China, contacts name: Jianrong Zhao, role: CONTACT, phone: 86+ 13848129952, email: zjr13848129952@163.com, geoPoint lat: 40.81056, lon: 111.65222, locations facility: Sir Run Run Hospital, Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Wenwen Li, role: CONTACT, phone: 86+ 13951644706, email: 546466035@qq.com, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Junwei Yang, role: CONTACT, phone: 86+ 18951767513, email: jwyang@njmu.edu.cn, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Nantong University, status: RECRUITING, city: Nantong, state: Jiangsu, zip: 226000, country: China, contacts name: Xinzhong Huang, role: CONTACT, phone: 86+ 13912288751, email: huangxz421@126.com, geoPoint lat: 32.03028, lon: 120.87472, locations facility: Shenyang Central Hospital, affiliated to Shenyang Medical College, status: RECRUITING, city: Shenyang, state: Liaoning, zip: 110000, country: China, contacts name: Zhenhua Ji, role: CONTACT, phone: 86+ 18002477058, email: jzh642@sina.com, geoPoint lat: 41.79222, lon: 123.43278, locations facility: General Hospital of Ningxia Medical University, status: RECRUITING, city: Yinchuan, state: Ningxia, zip: 750000, country: China, contacts name: Na Tian, role: CONTACT, phone: 86+ 13995216063, email: 13995216063@163.com, geoPoint lat: 38.46806, lon: 106.27306, locations facility: The First People's Hospital of Tancheng County, status: RECRUITING, city: Linyi, state: Shandong, zip: 276100, country: China, contacts name: Changyou Sun, role: CONTACT, phone: 86+ 15168960721, email: scy6119125@126.com, geoPoint lat: 35.06306, lon: 118.34278, locations facility: Qilu Hospital of Shandong University (Qingdao), status: RECRUITING, city: Qingdao, state: Shandong, zip: 266000, country: China, contacts name: Lanjie He, role: CONTACT, phone: 86+ 18561812668, email: nxhelanjie@126.com, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Minhang District Central Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Xudong Xu, role: CONTACT, phone: 86+ 18918169003, email: xxdmzx@sina.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai First People's Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Qiuling Fan, role: CONTACT, phone: 86+ 13904012680, email: cmufql@163.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai No.5 Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Jianying Niu, role: CONTACT, phone: 86+ 18918168518, email: njyphd2008@163.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai Tongji Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Chen Yu, role: CONTACT, phone: 86+ 13311996821, email: yuchen@tongji.edu.cn, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The Second Affiliated Hospital of Tianjin Medical University, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300000, country: China, contacts name: Rong Li, role: CONTACT, phone: 86+ 18698061623, email: beilloa@sohu.com, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Tianjin People's Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300000, country: China, contacts name: Gang Long, role: CONTACT, phone: 86+ 13602121007, email: longgang@hotmail.com, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False