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HyperkalemiaNCT06940414

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

An observational study of Hyperkalemia and Chronic Kidney Disease(CKD), run by Xiujuan Zang at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperkalemia, Chronic Kidney Disease(CKD)
How many people
1,890 participants
Where
1 siteChina
Study dates
28 Apr 2025to 30 Sep 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Aged 18 years or older with stable vital signs, specifically defined as:
  • Body temperature: 36.0°C-38.0°C;
  • Pulse: 50-120 beats/min;
  • Respiratory rate: 10-24 breaths/min;
  • Blood pressure: Systolic blood pressure ≥90 mmHg and diastolic blood pressure ≥60 mmHg.
  • Willing to participate in the study and sign the informed consent form.
  • Hematocrit (Hct) level between 25% and 60%.
  • Confirmed diagnosis of chronic kidney disease (CKD).

Who cannot join

  • 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.
Show all 9Show fewer
  • Patients unable to understand verbal or written instructions, including informed consent content.
  • Patients unable to cooperate with the study procedures.
  • Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiujuan Zang, MD contact

+8618918289268

zangxiujuan@shsmu.edu.cn

Xiangyu Zhang, MMed contact

+8618963755366

zhang_xiangyu@126.com

China1 site, 1 recruiting

  • Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Xiujuan Zang, Doctor of Medicine, +8618918289268, zangxiujuan@shsmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in a Community-Based Primary Care Setting

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.
Read more

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.

Being tested
No Intervention
Keywords
Hyperkalemia, Chronic Kidney Disease, Community-Based, Non-Dialysis, Prevalence, Eaglenos POCT System
Medical subject headings
Hyperkalemia, Renal Insufficiency, Chronic

What participants receive

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

  • No InterventionOther

    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.

What is being measured

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

  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.

    Measured: At the time of enrollment

Secondary outcomes (7)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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 (%).

    Measured: At the time of enrollment

Timeline

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

  1. First posted23 Apr 2025
  2. Study start28 Apr 2025
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion30 Sep 2025 (estimated)

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
Other
Time perspective
Cross-sectional
Enrolment
1,890 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06940414
Sponsor's protocol ID
2025-55-SJ-IRB
Status last verified
Apr 2025
First submitted
11 Apr 2025
Last updated
11 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD

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

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperkalemia and Chronic Kidney Disease(CKD), run by Xiujuan Zang at 1 site 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Xiujuan Zang, MD (+8618918289268, zangxiujuan@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Hyperkalemia. (time frame: At the time of enrollment). 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 NCT06940414, which also lists 8 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 11 Jul 2025.

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