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