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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04799067
Other study ID # D9480R00033
Secondary ID No secondary ID
Status Completed
Phase
First received
Last updated
Start date May 17, 2021
Est. completion date July 18, 2022

Study information

Verified date July 2023
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to evaluate the prevalence and recurrence of Hyperkalaemia (HK) in Chinese HD patients and to understand the treatment pattern of HK in China.


Description:

This is a prospective, cohort study. This study will include approximate 600 End Stage Renal Disease (ESRD) patients receiving Haemodialysis (HD) treatment twice a week or thrice a week. The assessments at enrolment and in follow-up are summarized as follow: Enrolment - Patients will be in Long Interdialytic interval (LIDI) at enrolment (V1). Demographic characteristics, medical history, etiology of ESRD, concomitant medications, dialysis vintage, an electrocardiogram (ECG), a pre-dialysis serum potassium measurement and a post- dialysis serum potassium measurement, blood routine, blood gas analysis and other blood biochemistry measurements, etc., will be obtained. Follow-up - Potassium measurements, including pre-dialysis potassium measurements at LIDI once every month (V3-V8), pre-dialysis potassium at SIDI during the first week (V2) for patients in HD thrice a week specifically, will be obtained. Concomitant medications, blood routine, blood gas analysis and other blood biochemistry measurements, etc., will be obtained


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date July 18, 2022
Est. primary completion date July 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patient aged = 18 years at the time of signing the informed consent. 2. Patients with ESRD and on haemodialysis (HD) 3. The HD treatment frequency is =2 sessions per week 4. Capable of giving signed informed consent Exclusion Criteria: 1. Acute kidney injury 2. Expected to receive renal transplantation within 6 months 3. Intracranial haemorrhage or elevated intracranial pressure within one month before enrolment 4. Shock that cannot be corrected by drugs within one month before enrolment 5. Failure to establish vascular access 6. Has been receiving peritoneal dialysis 7. Not suitable for this study judged by investigators

Study Design


Intervention

Other:
observational study
no study drug involved, observational study.

Locations

Country Name City State
China Research Site Beijing Beijing
China Research Site Guangzhou Guangdong
China Research Site Nanchang Jiangxi
China Research Site Ningbo Zhejiang
China Research Site Shanghai Shanghai
China Research Site Shenyang Liaoning
China Research Site Shenzhen Guangdong
China Research Site Shijiazhuang Hebei
China Research Site Taihe Hubei
China Research Site Taiyuan Shanxi
China Research Site Wenzhou Zhejiang
China Research Site Yangquan Shanxi

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients experiencing any HK at the study enrolment or during a 24-week follow-up Proportion of patients experiencing any HK (defined as serum potassium > 5.0 mmol/L) at the study enrolment or during a 24-week follow-up up to 24 weeks
Secondary Proportion of patients experiencing HK recurrence within 1, 2, 3, 4, 5 or 6 months (if applicable) during a 24-week follow-up including enrolment assessment Proportion of patients experiencing HK recurrence (defined as any HK event after the first HK event) within 1, 2, 3, 4, 5 or 6 months (if applicable) during a 24-week follow-up including enrolment assessment. A HK event is defined as any serum K+> 5.0 mmol/L within an interdialytic interval, which is usually two to three days. up to 24 weeks
Secondary Proportion of patients with 2, 3, 4, 5, 6 or more than 6 events of HK during a 24-week follow-up including enrolment assessment Proportion of patients with 2, 3, 4, 5, 6 or more than 6 events of HK during a 24-week follow-up including enrolment assessment up to 24 weeks
Secondary Intradialytic potassium shift at LIDI during the first week after patient enrolment Intradialytic potassium shift (defined as the difference between pre- and post-dialysis K+)at LIDI during the first week after patient enrolment up to 1 week
Secondary Serum K+ at LIDI and SIDI in patients receiving HD thrice a week during the first week after patient enrolment Serum K+ at LIDI and SIDI in patients receiving HD thrice a week during the first week after patient enrolment up to 1 week
Secondary Proportion of HK patients treated with any potassium binders and specific proportion of each potassium binder respectively during the 24-week follow up period Proportion of HK patients treated with any potassium binders including sodium polystyrene sulfonate ( calcium polystyrene sulfonate (CPS) or sodium zirconium cyclosilicate (SZC), and specific proportion of each potassium binder respectively during the 24-week follow up period up to 24 weeks
Secondary Proportion of HK events treated with any potassium binders including SPS, CPS or SZC among total number of HK events during the 24-week follow up period Proportion of HK events treated with any potassium binders among total number of HK events during the 24-week follow up period up to 24 weeks
Secondary Mean daily dose of SPS, CPS or SZC in patients treated with any potassium binder Mean daily dose of SPS, CPS or SZC in patients treated with any potassium binder up to 24 weeks
Secondary Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders up to 24 weeks
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