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HyperkalemiaPRECEDE-KNCT04799067

Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis

An observational study of Hyperkalemia and Hemodialysis, run by AstraZeneca at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
observational study
How many people
600 participants
Where
12 sitesChina
Study dates
17 May 2021to 18 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: ESRD patients receiving HD treatment twice a week or thrice a week.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Research Site

    Beijing, Beijing Municipality

  • Research Site

    Guangzhou, Guangdong

  • Research Site

    Nanchang, Jiangxi

  • Research Site

    Ningbo, Zhejiang

  • Research Site

    Shanghai, Shanghai Municipality, 2000127

  • Research Site

    Shenyang, Liaoning

  • Research Site

    Shenzhen, Guangdong

  • Research Site

    Shijiazhuang, Hebei

  • Research Site

    Taihe, Hubei

  • Research Site

    Taiyuan, Shanxi

  • Research Site

    Wenzhou, Zhejiang

  • Research Site

    Yangquan, Shanxi

Other trials in China

About this study

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

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.

Read the 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

Being tested
observational study
Keywords
Hyperkalemia
Medical subject headings
Hyperkalemia, Water-Electrolyte Imbalance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observational studyOther

    no study drug involved, observational study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 24 weeks

Secondary outcomes (8)

  1. 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.

    Measured: up to 24 weeks

  2. 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

    Measured: up to 24 weeks

  3. 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

    Measured: up to 1 week

  4. 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

    Measured: up to 1 week

  5. 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

    Measured: up to 24 weeks

  6. 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

    Measured: up to 24 weeks

  7. 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

    Measured: up to 24 weeks

  8. 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

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start17 May 2021
  3. Primary completion18 Jul 2022
  4. Study completion18 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04799067
Sponsor's protocol ID
D9480R00033
Other IDs
No secondary ID yet
Acronym
PRECEDE-K
Status last verified
Jul 2023
First submitted
24 Feb 2021
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39252179

  • Ni 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.

    PubMed 37559023

  • Ni 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.

    PubMed 34937724

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperkalemia and Hemodialysis, run by AstraZeneca at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients experiencing any HK at the study enrolment or during a 24-week follow-up (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04799067, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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