A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety and Treatment Pattern of Sodium Zirconium Cyclosilicate for Hyperkalaemia Management in Real World Practice in China
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1 other identifier
observational
1,000
1 country
27
Brief Summary
The study is a multi-center prospective (primary data) non-interventional cohort study which enrolls 1500 patients including new and ongoing users on SZC at Study Enrollment Day in real-world clinical practice. The eligible study patients will be identified by physicians in each study site by assessing the patients or reviewing the medical record. The prescription (including initiation, dose-adjusting or interruption) or discontinuation of SZC will be determined by physicians as per real-world clinical practice and in accordance with the local label. Any AZ employee, or member of the research operation team must not intervene in the decision-making of any physician or patient through any approach, at any time during the study. Every patient will be followed up according to standard clinical practice for 6 months from enrolment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
March 9, 2022
CompletedStudy Start
First participant enrolled
March 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2023
CompletedDecember 11, 2024
December 1, 2024
1.7 years
January 13, 2022
December 6, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Safety laboratory tests associated with AEs, SAEs and DAEs, specifically AEs
Serum electrolytes values（mmol/L）, serum BUN（mmol/L）, serum bicarbonate（mmol/L）, and others
From enrollment to the 6th month after Enrollment
The percentage of signs and symptoms associated with AEs, SAEs and DAEs, specifically AEs
The percentage of edema, constipation and others
From enrollment to the 6th month after Enrollment
Secondary Outcomes (3)
Safety laboratory tests associated with AEs, SAEs and DAEs, specifically AEs
From enrollment to the 6th month after Enrollment
The percentage of signs and symptoms associated with AEs, SAEs and DAEs, specifically AEs
From enrollment to the 6th month after enrollment
Medication information
From enrollment to the 6th month after enrollment
Eligibility Criteria
This study will enroll eligible Chinese patients who are new and ongoing users on SZC at Study Enrollment from approximately 60 sites in China recruiting 1500 patients. New users are defined that the patients without SZC treatment within 7 days before Study Enrollment Day take SZC treatment on Study Enrollment Day. Ongoing users are defined that the patients with SZC treatment within 7 days before Study Enrollment Day continue SZC treatment after enrollment. The patients with previous SZC treatment who will not continue taking SZC treatment after enrollment will not be included. Eligible patients will be those who meet all inclusion criteria but not any exclusion criteria. Eligible patients can be patients with or without hemodialysis treatment.
You may qualify if:
- Age ≥ 18 year-old
- Provision of patient informed consent prior to any study procedure
- HK (sK+ \> 5.0 mmol/L) diagnosed by physicians within 1 year before Study Enrolment Day
- Currently taking SZC, or has been prescribed and agree to start taking SZC since Study Enrolment Day.
You may not qualify if:
- Being unable to comply with study-specified procedures
- Has ever participated in current study before, or participating in any interventional study at Study Enrolment Day or within the last 3 months before Study Enrolment Day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (27)
Research Site
Anshan, China
Research Site
Beijing, China
Research Site
Benxi, China
Research Site
Changsha, China
Research Site
Changshu, China
Research Site
Chengdu, China
Research Site
Dalian, China
Research Site
Guangzhou, China
Research Site
Handan, China
Research Site
Hangzhou, China
Research Site
Hefei, China
Research Site
Hohhot, China
Research Site
Jiaxing, China
Research Site
Kunshan, China
Research Site
Linfen, China
Research Site
Nanjing, China
Research Site
Nanyang, China
Research Site
Ningbo, China
Research Site
Qidong, China
Research Site
Shijiazhuang, China
Research Site
Shiyan, China
Research Site
Taian, China
Research Site
Taishing, China
Research Site
Tianjin, China
Research Site
Wenzhou, China
Research Site
Xi'an, China
Research Site
Xinghua, China
Related Publications (1)
Shen N, Meng Q, Zhang L, Xie H, Zhao J, Xing C, Zuo L, Long G, Zhu Q, Shan C, Cai X, Yang J, Luo X, Wang J, Ye J, Wan X, Tian S, Wu Y, Lin Y, Yu X, Li Q, Liu X, Shi Z, Zhou J, Liu C, Cao Y, Wang N, Jiang X, Wu H, Hu Y, Li L, Wang Z, He J, Cao J, Wu F, Ma C, Yin X, Li Z, Wang H, Lin H. Evaluation of safety, effectiveness and treatment patterns of sodium zirconium cyclosilicate in management of hyperkalaemia in China: a real-world study protocol. BMJ Open. 2023 Mar 8;13(3):e070530. doi: 10.1136/bmjopen-2022-070530.
PMID: 36889826DERIVED
Related Links
Biospecimen
This study is a non-interventional study and will not collect the biospecimen.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hongli Lin, Doctor
The First Affiliated Hospital of Dalian Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2022
First Posted
March 9, 2022
Study Start
March 22, 2022
Primary Completion
December 6, 2023
Study Completion
December 6, 2023
Last Updated
December 11, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.