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CompletedNCT04466969HKRegistrypiloUpdated Sep 13, 2021

Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study

An observational study in Hyperkalemia, sponsored by AstraZeneca. Completed at 5 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-09-13.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
146
Ages
20 Years and older
Sex
All
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Study summary

Overall study aim of this study is to analyse descriptive statistics of Patient-Reported Outcome(PROs) which will be used in the Hyperkalemia(HK) registry study in hyperkalemia patients with Chronic Kidney Disease(CKD) or Heart Failure(HF) to describe the practice patterns of hyperkalemia treatment in in clinical practice. Based on these assessments, this study will provide the information for the applicability of PRO measurements which will be used in the Hyperkalemia registry study to the study population, i.e. CKD and/or HF patients with hyperkalemia

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Conditions studied

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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 146 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

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

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This study will include patients with hyperkalemia treated at outpatient clinics. Eligible patients will be screened through the regular visit to study sites in a consecutive manner. This study will be conducted in outpatient clinics in general hospitals. 150 hyperkalemia patients with CKD or HFrEF will be enrolled and assessed cross-sectionally.

After the written informed consent, subjects will be asked to complete the questionnaire-based survey.

Health-Related Quality of Life (HR-QoL), compliance to treatment with potassium binders, and other factors including age, sex, height, weight, smoking status, alcohol use and socio-economic status will be collected through the designated questionnaires. Information on disease status and on treatment patterns will be collected from physicians, and the latest results of laboratory tests will be collected from medical records (within 6 months before enrolment).

Inclusion criteria

  • Outpatients aged ≥20 years
  • Hyperkalemia patients defined as meeting either of the following criteria:

    1. Having a history of S-K ≥5.1 mmol/L ≥2 times within 6 months before enrolment
    2. Having a history of S-K ≥5.5 mmol/L once within 6 months before enrolment
    3. Currently treated by potassium binders for the treatment of hyperkalemia at enrolment
  • Having been diagnosed as CKD (≥stage 3b) or HFrEF by investigators as defined below:

CKD is diagnosed based on the guidelines of CKD issued by the Japanese Society of Nephrology (JSN, 2018) as being either or both of condition 1 and 2 for ≥3 months

  1. Clear sign of kidney impairment based on urinalysis, imaging, blood test, or biopsy. Especially, existence of ≥0.15 g/gCr of proteinuria (≥30 mg/gCr of albuminuria) is important.
  2. GFR \<45 mL/min/1.73m2 Within the routine clinical practice, GFR is estimated by serum creatinine, gender, and age using following the formulation.

eGFR creat (mL/min/1.73m2) = 194 x serum creatinine (mg/dL)-1.094 x age (years)-0.287 (for female patients, x 0.739)

≥Stage 3b CKD is diagnosed based on the following eGFR categories:

  • Stage 3b: 30 mL/min/1.73m2 ≤ eGFR \<45 mL/min/1.73m2
  • Stage 4: 15 mL/min/1.73m2 ≤ eGFR \<30 mL/min/1.73m2
  • Stage 5: eGFR \<15 mL/min/1.73m2

Patients with HFrEF is enrolled if patients meet following criteria within 6 months:

  1. EF ≤40%
  2. NYHA class II-IV

    • Provision of signed, written, and detailed informed consent
    • Signed written informed consent by themselves

Exclusion criteria

Exclusion Criteria:

  • Currently on any chronic RRT (including hemodialysis or peritoneal dialysis >30 days, or kidney transplant) within 6 months before enrolment
  • Patients with acute kidney injury at enrolment •Patients who took blood transfusion or potassium supplements within 6 months before enrolment
  • Active malignancy or life expectancy of less than 6 months.
  • Patients who have GI disturbance/chronic diarrhoea/stoma, and investigators determine those affect significantly serum K level
  • Patients who have autoimmune disorders, and investigators determine those affect significantly serum K level
  • Patients whose lab data have suspicion for pseudohyperkalemia
  • Patients who are pregnant, lactating, or planning to become pregnant
  • Current participation in interventional studies and/or clinical trials
  • Patients who, in the opinion of the investigators, would be unlikely to comply with self-assessments
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
146 participants (actual)
Patient registry
No

Groups and cohorts

  • HF

    Patients with HF with reduced Ejection Fraction (HFrEF) is enrolled if patients meet following criteria within 6 months: 1. Ejection Fraction ratio(EF) ≤40% 2. New York Heart Association(NYHA) class II-IV

  • stages of CKD (stage 3b)

    CKD is diagnosed based on the following e Glomerular Filtration Rate (eGFR) categories: Stage 3b: 30 mL/min/1.73m2 ≤ eGFR \<45 mL/min/1.73m2

  • Stages of CKD (stage 4)

    CKD is diagnosed based on the following eGFR categories: 15 mL/min/1.73m2 ≤ eGFR \<30 mL/min/1.73m2

  • stages of CKD (stage 5)

    CKD is diagnosed based on the following eGFR categories: eGFR \<15 mL/min/1.73m2

  • Treated by potassium binders

    Patients who have been treated by Potassium Binders

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What researchers measure

Primary outcomes

  1. Analyse descriptive statistics of PROs

    The primary focus of this study is to analyse descriptive statistics of PROs which will be used in the Hyperkalemia registry. Information on demographics, medical history, treatment patterns, medication compliance, and self-reported questionnaire will be collected.

    Time frame: 4weeks

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Study locations

5 sites
  • Research Site
    Nagoyashi, Aichi 457-8511, Japan
  • Research Site
    Matsudoshi, Chiba 271-0077, Japan
  • Research Site
    Iizukashi, Fukuoka 820-8505, Japan
  • Research Site
    Sashimagun, Ibaraki 306-0433, Japan
  • Research Site
    Tsuchiurashi, Ibaraki 300-0028, Japan
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References and documents

Related links

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04466969
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jul 10, 2020
Start date
Jul 31, 2020
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020
Last update
Sep 13, 2021

Oversight

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

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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