PMID- 36889826
OWN - NLM
STAT- MEDLINE
DCOM- 20230312
LR  - 20230314
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 13
IP  - 3
DP  - 2023 Mar 8
TI  - Evaluation of safety, effectiveness and treatment patterns of sodium zirconium 
      cyclosilicate in management of hyperkalaemia in China: a real-world study 
      protocol.
PG  - e070530
LID - 10.1136/bmjopen-2022-070530 [doi]
LID - e070530
AB  - INTRODUCTION: Hyperkalaemia (HK) is a potentially life-threatening electrolyte 
      imbalance associated with several adverse clinical outcomes. The efficacy and 
      negative effects of currently existing treatment options have made HK management 
      questionable. Sodium zirconium cyclosilicate (SZC), a novel highly selective 
      potassium binder, is approved for the treatment of HK. The present study will be 
      aimed to assess the safety, effectiveness and treatment patterns of SZC in 
      Chinese patients with HK in a real-world clinical setting as it is required by 
      China's drug review and approval process. METHODS AND ANALYSIS: This is a 
      multicentre, prospective cohort study which plans to enrol 1000 patients taking 
      SZC or willing to take SZC from approximately 40 sites in China. Patients >/=18 
      years of age at the time of signing the written informed consent and with 
      documented serum potassium levels >/=5.0 mmol/L within 1 year before study 
      enrolment day will be included. Eligible patients will receive SZC treatment and 
      will be followed up for 6 months from enrolment day. The primary objective will 
      be to evaluate the safety of SZC for the management of HK in Chinese patients in 
      terms of adverse events (AEs), serious AEs as well as discontinuation of SZC. The 
      secondary objectives will include understanding the SZC dosage information in 
      terms of its effectiveness and treatment patterns under real-world clinical 
      practice and assessing effectiveness of SZC during the observational period. 
      ETHICS AND DISSEMINATION: This study protocol was approved by the Ethics 
      Committee of the First Affiliated Hospital of Dalian Medical University (approval 
      number: YJ-JG-YW-2020). All the participating sites have received the ethics 
      approval. Results will be disseminated through national and international 
      presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: 
      NCT05271266.
CI  - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Shen, Nan
AU  - Shen N
AUID- ORCID: 0000-0002-4522-6762
AD  - Department of Nephrology, First Affiliated Hospital of Dalian Medical University, 
      Dalian, China.
FAU - Meng, Qingyang
AU  - Meng Q
AD  - Department of Nephrology, First Affiliated Hospital of Dalian Medical University, 
      Dalian, China.
FAU - Zhang, Lihong
AU  - Zhang L
AD  - Department of Nephrology, The First Hospital of Hebei Medical University, 
      Shijiazhuang, China.
FAU - Xie, Hua
AU  - Xie H
AD  - Department of Nephrology, Dalian Ruikaier Renal Disease Hospital, Dalian, China.
FAU - Zhao, Jianrong
AU  - Zhao J
AD  - Department of Nephrology, The Affiliated Hospital of Inner Mongolia Medical 
      University, Hohhot, China.
FAU - Xing, Changying
AU  - Xing C
AD  - Department of Nephrology, Jiangsu Province Official Hospital, Nanjing, China.
FAU - Zuo, Li
AU  - Zuo L
AD  - Department of Nephrology, Peking University People's Hospital, Beijing, China.
FAU - Long, Gang
AU  - Long G
AD  - Department of Nephrology, Tianjin People's Hospital, Tianjin, China.
FAU - Zhu, Qiang
AU  - Zhu Q
AD  - Department of Nephrology, Xinghua People's Hospital, Xinghua, China.
FAU - Shan, Chunyan
AU  - Shan C
AD  - Department of Nephrology, Chu Hsien-I Memorial Hospital of Tianjin Medical 
      University, Tianjin, China.
FAU - Cai, Xudong
AU  - Cai X
AD  - Department of Nephrology, Ningbo Traditional Chinese Medicine Hospital, Ningbo, 
      China.
FAU - Yang, Jing
AU  - Yang J
AD  - Department of Nephrology, Hefei First People's Hospital, Hefei, China.
FAU - Luo, Xun
AU  - Luo X
AD  - Department of Nephrology, Hunan Provincial People's Hospital, Changsha, China.
FAU - Wang, Jianmin
AU  - Wang J
AD  - Department of Nephrology, Linfen Central Hospital, Linfen, China.
FAU - Ye, Jianming
AU  - Ye J
AD  - Department of Nephrology, First People's Hospital of Kunshan, Kunshan, China.
FAU - Wan, Xin
AU  - Wan X
AD  - Department of Nephrology, The First Hospital of Nanjing, Nanjing, China.
FAU - Tian, Shaojiang
AU  - Tian S
AD  - Department of Nephrology, Shiyan People's Hospital, Shiyan, China.
FAU - Wu, Yifan
AU  - Wu Y
AD  - Department of Nephrology, Guangdong Provincial Hospital of Traditional Chinese 
      Medicine, Guangzhou, China.
FAU - Lin, Yongqiang
AU  - Lin Y
AD  - Department of Nephrology, Wenzhou Integrated Chinese and Western Medicine 
      Hospital, Wenzhou, China.
FAU - Yu, Xiaoyong
AU  - Yu X
AD  - Department of Nephrology, Shanxi Provincial Hospital of Chinese Medicine, Xi'an, 
      China.
FAU - Li, Qing
AU  - Li Q
AD  - Department of Nephrology, Tianjin Teda Hospital, Tianjin, China.
FAU - Liu, Xinyu
AU  - Liu X
AD  - Department of Nephrology, Nanyang Central Hospital, Nanyang, China.
FAU - Shi, Zhenwei
AU  - Shi Z
AD  - Department of Nephrology, The First Hospital of Tsinghua University, Beijing, 
      China.
FAU - Zhou, Jingwei
AU  - Zhou J
AD  - Dongzhimen Hospital Beijing University of Chinese Medicine, Beijing, China.
FAU - Liu, Chunyan
AU  - Liu C
AD  - Department of Nephrology, Second Affiliated Hospital of Dalian Medical 
      University, Dalian, China.
FAU - Cao, Yanping
AU  - Cao Y
AD  - Department of Nephrology, Handan First Hospital, Handan, China.
FAU - Wang, Niansong
AU  - Wang N
AD  - Department of Nephrology, The Sixth People's Hospital Affiliated to Medical 
      College of Shanghai Jiaotong University, Shanghai, China.
FAU - Jiang, Xinxin
AU  - Jiang X
AD  - Department of Nephrology, Sandun District of Zhejiang Hospital, Hangzhou, China.
FAU - Wu, Henglan
AU  - Wu H
AD  - Department of Nephrology, First Hospital of Jiaxing, Jiaxing, China.
FAU - Hu, Yao
AU  - Hu Y
AD  - Department of Nephrology, Clinical Medical College and Affiliated Hospital of 
      Chengdu University, Chengdu, China.
FAU - Li, Lu
AU  - Li L
AD  - Department of Nephrology, Xi'an First Hospital Affiliated to Xi'an Medical 
      University, Xi'an, China.
FAU - Wang, Zhaohua
AU  - Wang Z
AD  - Department of Nephrology, Taian City Central Hospital, Taian, China.
FAU - He, Jingdong
AU  - He J
AD  - Department of Nephrology, Nuclear Industry 416 Hospital, Chengdu, China.
FAU - Cao, Juan
AU  - Cao J
AD  - Department of Nephrology, Taixing People's Hospital, Taizhou, China.
FAU - Wu, Fenglei
AU  - Wu F
AD  - Department of Nephrology, Qidong People's Hospital, Qidong, China.
FAU - Ma, Cong
AU  - Ma C
AD  - Department of Nephrology, Anshan Central Hospital, Anshan, China.
FAU - Yin, Xun
AU  - Yin X
AD  - Department of Nephrology, Changshu No 2 People's Hospital, Changshu, China.
FAU - Li, Zhongxin
AU  - Li Z
AD  - Department of Nephrology, Beijing Luhe Hospital, Capital Medical University, 
      Beijing, China.
FAU - Wang, Huimin
AU  - Wang H
AD  - Department of Nephrology, Liaoning Health Industry Group Bensteel General 
      Hospital, Liaoning, China.
FAU - Lin, Hongli
AU  - Lin H
AD  - Department of Nephrology, First Affiliated Hospital of Dalian Medical University, 
      Dalian, China linhongli@vip.163.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT05271266
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230308
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - RWP5GA015D (Potassium)
RN  - D652ZWF066 (sodium zirconium cyclosilicate)
SB  - IM
MH  - Humans
MH  - China
MH  - *Hyperkalemia/drug therapy
MH  - Potassium
MH  - Prospective Studies
MH  - Multicenter Studies as Topic
PMC - PMC10008460
OTO - NOTNLM
OT  - adult nephrology
OT  - general medicine (see internal medicine)
OT  - kidney & urinary tract disorders
OT  - nephrology
COIS- Competing interests: None declared.
EDAT- 2023/03/09 06:00
MHDA- 2023/03/11 06:00
PMCR- 2023/03/08
CRDT- 2023/03/08 20:53
PHST- 2023/03/08 20:53 [entrez]
PHST- 2023/03/09 06:00 [pubmed]
PHST- 2023/03/11 06:00 [medline]
PHST- 2023/03/08 00:00 [pmc-release]
AID - bmjopen-2022-070530 [pii]
AID - 10.1136/bmjopen-2022-070530 [doi]
PST - epublish
SO  - BMJ Open. 2023 Mar 8;13(3):e070530. doi: 10.1136/bmjopen-2022-070530.