Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis
PRECEDE-K
2 other identifiers
observational
600
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedStudy Start
First participant enrolled
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2022
CompletedJuly 6, 2023
July 1, 2023
1.2 years
February 24, 2021
July 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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
up to 24 weeks
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
Intradialytic potassium shift at LIDI during the first week after patient enrolment
up to 1 week
Serum K+ at LIDI and SIDI in patients receiving HD thrice a week during the first week after patient enrolment
up to 1 week
Proportion of HK patients treated with any potassium binders and specific proportion of each potassium binder respectively during the 24-week follow up period
up to 24 weeks
- +3 more secondary outcomes
Interventions
no study drug involved, observational study.
Eligibility Criteria
ESRD patients receiving HD treatment twice a week or thrice a week.
You may qualify if:
- Patient aged ≥ 18 years at the time of signing the informed consent.
- Patients with ESRD and on haemodialysis (HD)
- The HD treatment frequency is ≥2 sessions per week
- Capable of giving signed informed consent
You may not qualify if:
- Acute kidney injury
- Expected to receive renal transplantation within 6 months
- Intracranial haemorrhage or elevated intracranial pressure within one month before enrolment
- Shock that cannot be corrected by drugs within one month before enrolment
- Failure to establish vascular access
- Has been receiving peritoneal dialysis
- Not suitable for this study judged by investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
Research Site
Beijing, Beijing Municipality, China
Research Site
Guangzhou, Guangdong, China
Research Site
Shenzhen, Guangdong, China
Research Site
Shijiazhuang, Hebei, China
Research Site
Taihe, Hubei, China
Research Site
Nanchang, Jiangxi, China
Research Site
Shenyang, Liaoning, China
Research Site
Shanghai, Shanghai Municipality, 2000127, China
Research Site
Taiyuan, Shanxi, China
Research Site
Yangquan, Shanxi, China
Research Site
Ningbo, Zhejiang, China
Research Site
Wenzhou, Zhejiang, China
Related Publications (3)
Jin H, Lu R, Zhang L, Yao L, Shao G, Zuo L, Qin S, Zhang X, Zhang Q, Yu W, Luo Q, Ren Y, Peng H, Xiao J, Yang Q, Chen Q, Shi Y, Ni Z. Hyperkalemia burden and treatment patterns in Chinese patients on hemodialysis: final analysis of a prospective multicenter cohort study (PRECEDE-K). Ren Fail. 2024 Dec;46(2):2384585. doi: 10.1080/0886022X.2024.2384585. Epub 2024 Sep 9.
PMID: 39252179DERIVEDNi Z, Jin H, Lu R, Zhang L, Yao L, Shao G, Zuo L, Qin S, Zhang X, Zhang Q, Yu W, Luo Q, Ren Y, Peng H, Xiao J, Yang Q, Chen Q, Shi Y; PRECEDE-K study group. Hyperkalaemia prevalence and dialysis patterns in Chinese patients on haemodialysis: an interim analysis of a prospective cohort study (PRECEDE-K). BMC Nephrol. 2023 Aug 9;24(1):233. doi: 10.1186/s12882-023-03261-8.
PMID: 37559023DERIVEDNi Z, Jin H, Lu R, Zuo L, Yu W, Ren Y, Yang Q, Xiao J, Zhang Q, Zhang L, Zhang X, Chen Q, Chen C, Shao G, Luo Q, Yao L, Qin S, Peng H, Zhao Q; PRECEDE-K Study group. Hyperkalaemia prevalence, recurrence and treatment in patients on haemodialysis in China: protocol for a prospective multicentre cohort study (PRECEDE-K). BMJ Open. 2021 Dec 22;11(12):e055770. doi: 10.1136/bmjopen-2021-055770.
PMID: 34937724DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2021
First Posted
March 16, 2021
Study Start
May 17, 2021
Primary Completion
July 18, 2022
Study Completion
July 18, 2022
Last Updated
July 6, 2023
Record last verified: 2023-07