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RecruitingNCT06940414Updated Jul 11, 2025

Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community

An observational study in Hyperkalemia and Chronic Kidney Disease(CKD), sponsored by Xiujuan Zang. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-11.

Sponsored by Xiujuan Zang · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Apr 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
1,890
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to investigate the prevalence and risk factors of hyperkalemia in community-based non-dialysis chronic kidney disease (CKD) patients. The main questions it aims to answer are:

  1. What is the prevalence of hyperkalemia in non-dialysis CKD patients in a primary care setting?
  2. What are the key risk factors influencing the occurrence of hyperkalemia in this population? Researchers will collect clinical and demographic data from participants across 18 community health centers and use both point-of-care testing (POCT) and laboratory-based methods to measure serum potassium levels and related parameters.

Participants will:

  1. Provide blood samples for POCT and laboratory testing.
  2. Participate in interviews or questionnaires to gather clinical and lifestyle information.

The findings will be used to construct a risk prediction model for hyperkalemia, aiming to optimize screening pathways and improve disease management strategies in primary care.

Read the detailed description

Hyperkalemia is a common and life-threatening complication in CKD, with limited data available for non-dialysis patients in community settings. This cross-sectional study will enroll 2,000 non-dialysis CKD patients (Stages 1-5) from 18 community health centers in Songjiang, Shanghai.

The study includes:

  1. Validation phase: 500 participants to validate POCT devices for measuring whole blood potassium, glucose, creatinine, uric acid, and hemoglobin.
  2. Main phase: 1,500 participants to assess hyperkalemia prevalence and risk factors.

Data will be collected through:

  1. POCT and laboratory testing of blood samples.
  2. Structured questionnaires capturing demographics, comorbidities, and lifestyle factors.

Statistical analyses will identify key risk factors, and a predictive model will be developed to guide early screening and intervention. This study aims to improve CKD management in primary care by providing evidence for targeted hyperkalemia screening and prevention strategies.

02

Conditions studied

  • Hyperkalemia
  • Chronic Kidney Disease(CKD)

Keywords

  • Hyperkalemia
  • Chronic Kidney Disease
  • Community-Based
  • Non-Dialysis
  • Prevalence
  • Eaglenos POCT System
03

In context

Hyperkalemia

133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.

This study's planned enrollment of 1,890 is above the median of 459 across 30 observational studies indexed under Hyperkalemia.

Browse Hyperkalemia studies →

Lead sponsor

This is the only study on the registry with Xiujuan Zang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Non-dialysis CKD patients (Stage 1-5), aged 18 years or older, recruited from 18 community health centers in Songjiang District, Shanghai.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18 years or older with stable vital signs, specifically defined as:

    1. Body temperature: 36.0°C-38.0°C;
    2. Pulse: 50-120 beats/min;
    3. Respiratory rate: 10-24 breaths/min;
    4. Blood pressure: Systolic blood pressure ≥90 mmHg and diastolic blood pressure ≥60 mmHg.
  • Willing to participate in the study and sign the form.
  • Hematocrit (Hct) level between 25% and 60%.
  • Confirmed diagnosis of chronic kidney disease (CKD).

Exclusion criteria

Exclusion Criteria:

  • Patients in the unstable phase of acute cardiovascular or cerebrovascular diseases (e.g., acute cerebral infarction, cerebral hemorrhage, or acute coronary syndrome).
  • Patients in the unstable phase of severe acute diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic coma).
  • Patients currently in the acute kidney injury (AKI) stage.
  • Patients who have started renal replacement therapy.
  • Pregnant or breastfeeding women.
  • Patients currently participating in or who have participated in other clinical trials within the past six months.
  • Patients unable to understand verbal or written instructions, including content.
  • Patients unable to cooperate with the study procedures.
  • Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
1,890 participants (estimated)
Patient registry
No

Interventions

  • OtherNo Intervention

    This is an observational study with no interventions. POCT devices, provided by Eaglenos Sciences, Inc., are used to measure blood glucose, creatinine, uric acid, hemoglobin, and potassium levels in non-dialysis CKD patients for data collection purposes only.

06

What researchers measure

Primary outcomes

  1. Prevalence of Hyperkalemia.

    The proportion of non-dialysis CKD patients with hyperkalemia, defined as a blood potassium level greater than 5.0 mmol/L, measured using point-of-care testing (POCT) at enrollment.

    Time frame: At the time of enrollment

Secondary outcomes

  1. Association Between Hyperkalemia and Age.

    Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and age (years) in non-dialysis CKD patients at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses.

    Time frame: At the time of enrollment

  2. Association Between Hyperkalemia and CKD Stage.

    Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and CKD stage (1-5) in non-dialysis CKD patients at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses.

    Time frame: At the time of enrollment

  3. Association Between Hyperkalemia and Blood Glucose.

    Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and blood glucose (mmol/L) in non-dialysis CKD patients using POCT at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses.

    Time frame: At the time of enrollment

  4. Association Between Hyperkalemia and Creatinine.

    Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and creatinine (μmol/L) in non-dialysis CKD patients using POCT at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses

    Time frame: At the time of enrollment

  5. Association Between Hyperkalemia and Uric Acid.

    Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and uric acid (μmol/L) in non-dialysis CKD patients using POCT at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses.

    Time frame: At the time of enrollment

  6. Association Between Hyperkalemia and Hemoglobin.

    Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and hemoglobin (g/L) in non-dialysis CKD patients using POCT at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses.

    Time frame: At the time of enrollment

  7. Performance of Hyperkalemia Prediction Model.

    Assesses the performance of a hyperkalemia prediction model in non-dialysis CKD patients using data from enrollment, reported as area under the ROC curve (AUC), sensitivity (%), and specificity (%).

    Time frame: At the time of enrollment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Sevamontree C, Jintajirapan S, Phakdeekitcharoen P, Phakdeekitcharoen B. The Prevalence and Risk Factors of Hyperkalemia in the Outpatient Setting. Int J Nephrol. 2024 Jan 22;2024:5694131. doi: 10.1155/2024/5694131. eCollection 2024. PubMed 38292832 ↗
  • Sinnathamby ES, Banh KT, Barham WT, Hernandez TD, De Witt AJ, Wenger DM, Klapper VG, McGregor D, Paladini A, Ahmadzadeh S, Shekoohi S, Kaye AD, Varrassi G. Hyperkalemia: Pharmacotherapies and Clinical Considerations. Cureus. 2024 Jan 26;16(1):e52994. doi: 10.7759/cureus.52994. eCollection 2024 Jan. PubMed 38406030 ↗
  • Einhorn LM, Zhan M, Hsu VD, Walker LD, Moen MF, Seliger SL, Weir MR, Fink JC. The frequency of hyperkalemia and its significance in chronic kidney disease. Arch Intern Med. 2009 Jun 22;169(12):1156-62. doi: 10.1001/archinternmed.2009.132. PubMed 19546417 ↗
  • Gilligan S, Raphael KL. Hyperkalemia and Hypokalemia in CKD: Prevalence, Risk Factors, and Clinical Outcomes. Adv Chronic Kidney Dis. 2017 Sep;24(5):315-318. doi: 10.1053/j.ackd.2017.06.004. PubMed 29031358 ↗
  • De Nicola L, Di Lullo L, Paoletti E, Cupisti A, Bianchi S. Chronic hyperkalemia in non-dialysis CKD: controversial issues in nephrology practice. J Nephrol. 2018 Oct;31(5):653-664. doi: 10.1007/s40620-018-0502-6. Epub 2018 Jun 7. PubMed 29882199 ↗
  • Montford JR, Linas S. How Dangerous Is Hyperkalemia? J Am Soc Nephrol. 2017 Nov;28(11):3155-3165. doi: 10.1681/ASN.2016121344. Epub 2017 Aug 4. PubMed 28778861 ↗
  • Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6. PubMed 22386035 ↗
  • Ene-Iordache B, Perico N, Bikbov B, Carminati S, Remuzzi A, Perna A, Islam N, Bravo RF, Aleckovic-Halilovic M, Zou H, Zhang L, Gouda Z, Tchokhonelidze I, Abraham G, Mahdavi-Mazdeh M, Gallieni M, Codreanu I, Togtokh A, Sharma SK, Koirala P, Uprety S, Ulasi I, Remuzzi G. Chronic kidney disease and cardiovascular risk in six regions of the world (ISN-KDDC): a cross-sectional study. Lancet Glob Health. 2016 May;4(5):e307-19. doi: 10.1016/S2214-109X(16)00071-1. PubMed 27102194 ↗

Individual participant data

Plan to share: Yes — All collected IPD

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Starting 6 months after publication

Access criteria: Data will be made available to qualified researchers upon submission of a research proposal and executionof a data use agreement. Data access will be granted after the final study results are published and after anethical review by the institution's ethics board. Data sharing will be coordinated via email. Qualifiedresearchers can contact zxyykjb@163.com to request access to the data.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2025 (actual). Primary completion is estimated for Jul 2025, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2025
First posted
Apr 23, 2025
StartActual
Apr 28, 2025
Primary completionEst.
Jul 31, 2025
CompletionEst.
Sep 30, 2025
Last update
Jul 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06940414
Lead sponsor
Xiujuan Zang
Responsible party
Xiujuan Zang (Chief of Nephrology, Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine) — Sponsor-investigator
First posted
Apr 23, 2025
Start date
Apr 28, 2025
Primary completion
Jul 31, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Jul 11, 2025

Study contacts

Xiujuan Zang, MD
Contact
zangxiujuan@shsmu.edu.cn
+8618918289268
Xiangyu Zhang, MMed
Contact
zhang_xiangyu@126.com
+8618963755366
Xiujuan Zang, MD
principal investigator · Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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