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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05271266
Other study ID # D9483R00001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 22, 2022
Est. completion date December 6, 2023

Study information

Verified date June 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


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Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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 Medication information SZC dosage(g), etc From enrollment to the 6th month after enrollment
See also
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Terminated NCT04727528 - Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease Phase 3
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Completed NCT05462119 - Safety of Oral Resin for Treatment of Hyperkalemia in Chinese Patients With Renal Insufficiency
Terminated NCT04997161 - Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia Phase 4
Recruiting NCT03813407 - An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia Phase 3