Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Hyperkalaemia
Eligibility:
All Genders
18+ years
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...
Detailed Description
Background/Rationale: Hyperkalaemia (HK) is a common electrolyte disturbance in clinical practice, defined as serum potassium (sK) beyond the normal range. The cut-off value for HK diagnosis is 5.0 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 6 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05271266
Start Date
March 22 2022
End Date
December 6 2023
Last Update
December 11 2024
Active Locations (27)
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1
Research Site
Anshan, China
2
Research Site
Beijing, China
3
Research Site
Benxi, China
4
Research Site
Changsha, China