Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis

Hemodialysis Clinical Trial

— PRECEDE-K  

Official title:

Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis: A Prospective Multi-centre Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04799067
• Other study ID #: D9480R00033
• Secondary ID: No secondary ID
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hemodialysis
• Hyperkalemia
• Recurrence
• Water-Electrolyte Imbalance

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

External Links

•   redacted CSR Synopsis