Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT04799067
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2021-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis: A Prospective Multi-centre Cohort Study
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECEDE-K
Brief 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.
Detailed 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| No secondary ID yet | OTHER | No secondary ID yet | View |