HyperkalemiaHK registryNCT05297409
An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure
An observational study of Hyperkalemia, run by AstraZeneca at 32 sites in Japan.
Trial summary
This prospective observational research will be conducted to assess the burden of hyperkalemia including treatment and disease burden of patients in a long-term continuous care from various aspects including adherence to the medication for hyperkalemia and HR-QoLs. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperkalemia
- How many people
- 352 participants
- Where
- 32 sitesJapan
- Study dates
- 21 May 2022to 28 Aug 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult out-patients with CKD stage 3b, stage 4, or stage 5, or with HF (NYHA class II-IV) who are being treated with potassium binders for hyperkalemia at the time of enrolment, and who started receiving potassium binders within 6 months before enrolment
Who may be able to join
- Patients with hyperkalemia who meet the following criteria:
- 1) Being treated with potassium binders for hyperkalemia at the time of enrolment, and having started receiving potassium binders within 6 months before enrolment
- Having been diagnosed as CKD (≥stage 3b) or HF diagnosed by investigators, and as defined below:
- 1) CKD is diagnosed based on the CKD guidelines issued by the Japanese Society of Nephrologyxxix as being either or both of condition 1 and 2 for ≥3 months
- 1-i) Clear signs of kidney impairment based on the results of urinalysis, imaging, blood test, or biopsy. Presence of proteinuria, especially more than 0.15 g/gCr (albuminuria more than 30 mg/gCr).
- 1-ii) GFR <45 mL/min/1.73m2
- 2) Patients with HFwill be enrolled if patients meet following criteria: 2-i) NYHA class II-IV, within 6 months 2-ii) Patients with a diagnosis or history of heart failure, hospitalization, and laboratory records of any of the following; NT-proBNP≥400 pg/ml or BNP≥100 pg/ml, or pathological findings such as abnormal cardiac function by UCG/CT/MRI/catheterization/nuclear medicine examination
- Provision of signed, written, and detailed informed consent
Who cannot join
- 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 (AKI)* within 6 months before enrolment
- Patients with acute heart failure within 3 months before enrolment
- Patients who received blood transfusion within 6 months before enrolment
- Patients with active malignancy or whose life expectancy is less than 6 months
- GI disturbance, chronic diarrhoea, or GI stoma if, as judged by the investigators, that condition or its treatment has an important impact on S-K values
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- Autoimmune disease if, as judged by the investigators, that condition or its treatment has an important impact on S-K values
- Patients who are suspected, on the basis of laboratory data, to have pseudohyperkalemia (abnormality in the sample, a history of severe leukocytopenia or thrombocytopenia)
- Patients with recent traumatic injury
- Patients who are pregnant, lactating, or planning to become pregnant
- Current participation in a clinical trials, i.e. an interventional studies
- Presence of a condition that, in the opinion of the investigator, i) would places the subject at undue risk, or ii) would potentially jeopardizes the quality of the data to be generated, or iii) would prevent the patient from performing protocol-defined tasks for physical or mental reasons, or iv) would prevent the patient from understanding the contents of the self-administered questionnaire and responding to its questions on his/her own, or v) would, for some other reason, make the patient inappropriate for this study.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Japan32 sites
Research Site
Azumino, Nagano, 399-8292
Research Site
Bunkyo, Tokyo, 113-8431
Research Site
Bunkyo, Tokyo, 113-8519
Research Site
Chikushino-shi, Fukuoka, 818-0058
Research Site
Fukuyama, Hiroshima, 729-0104
Research Site
Hakusan, Ishikawa-ken, 924-8588
Research Site
Hirosima-shi,Naka-ku, Hiroshima, 730-8518
Research Site
Iizuka-shi, Fukuoka, 820-8505
Research Site
Kagoshima, 890-0075
Research Site
Kanazawa, Ishikawa-ken, 920-8650
Research Site
Kasugai, Aichi-ken, 486-8510
Research Site
Kawasaki-shi,Kawasaki-ku, Kanagawa, 210-0852
Research Site
Kawasaki-shi,Miyamae-ku, Kanagawa, 216-8511
Research Site
Kitakyushu-shi, Fukuoka, 802-8555
Research Site
Kochi, 781-0082
Research Site
Kuwana, Mie-ken, 511-0061
Research Site
Matsudo, Chiba, 271-0077
Research Site
Nagaoka, Aichi-ken, 457-8511
Research Site
Nagaoka, Aichi-ken, 460-0001
Research Site
Nagaoka, Niigata, 940-8653
Research Site
Osaka-shi,Kita-ku, Osaka, 530-0012
Research Site
Sakai, Osaka, 593-8304
Research Site
Sendai, Miyagi, 982-8502
Research Site
Shizuoka, 410-2295
Research Site
tabashi City, Tokyo, 173-0032
Research Site
tabashi City, Tokyo, 173-8610
Research Site
Takasaki, Gunma, 370-0001
Research Site
Takasaki, Gunma, 370-8537
Research Site
Tochigi, 321-0293
Research Site
Toyama, 939-8511
Research Site
Ueda, Nagano, 386-8610
Research Site
Yamagata, 990-8533
About this study
Official title: Hyperkalemia Registry An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure
This prospective observational research will be conducted to assess the burden of hyperkalemia including treatment and disease burden of patients in a long-term continuous care from various aspects including adherence to the medication for hyperkalemia and HR-QoLs.
- Conditions
- Hyperkalemia
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyperkalemia patient with Chronic kidney disease | Not described | |
| hyperkalemia patient with heart failure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics including socio-demographic variables, severity of disease and comorbidities
Measured: 6 month
Health-Related Quality of Life
Measured: 6 month
Serum Potassium
Measured: 6 month
Secondary outcomes (3)
Nutritional status
Measured: 6 month
Status of metabolic acidosis
Measured: 6 month
Use of healthcare resource
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start21 May 2022
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297409
- Sponsor's protocol ID
- D9480R00027
- Acronym
- HK registry
- Status last verified
- Jul 2025
- First submitted
- 17 Mar 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials 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.
Publications
Sada KE, Yamazaki H, Wakita T, Yamamoto Y, Wang J, Onishi Y, Hamada T, Ide R, Takeda M, Fukuhara S, Shibagaki Y. Quality of life in hyperkalemia: baseline analysis of a cohort study of management of hyperkalemia in patients with chronic kidney disease or heart failure in Japan. Clin Exp Nephrol. 2026 Oct 6. doi: 10.1007/s10157-026-02951-5. Online ahead of print.
PubMed 42837068Shibagaki Y, Yamazaki H, Wakita T, Ware JE, Wang J, Onishi Y, Yajima T, Sada KE, Yamamoto Y, Fukuhara S. Impact of treatment of hyperkalaemia on quality of life: design of a prospective observational cohort study of long-term management of hyperkalaemia in patients with chronic kidney disease or chronic heart failure in Japan. BMJ Open. 2023 Dec 14;13(12):e074090. doi: 10.1136/bmjopen-2023-074090.
PubMed 38101840
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperkalemia Registry An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure
- ClinicalTrials.gov ID
- NCT05297409
- Acronym / sponsor ID
- HK registry / D9480R00027
- Conditions
- Hyperkalemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 May 2022 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational research will be conducted to assess the burden of hyperkalemia including treatment and disease burden of patients in a long-term continuous care from various aspects including adherence to the medication for hyperkalemia and HR-QoLs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperkalemia patient with Chronic kidney disease | – | – |
| hyperkalemia patient with heart failure | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult out-patients with CKD stage 3b, stage 4, or stage 5, or with HF (NYHA class II-IV) who are being treated with potassium binders for hyperkalemia at the time of enrolment, and who started receiving potassium binders within 6 months before enrolment
Key inclusion criteria (8 listed)
- Patients with hyperkalemia who meet the following criteria:
- 1) Being treated with potassium binders for hyperkalemia at the time of enrolment, and having started receiving potassium binders within 6 months before enrolment
- Having been diagnosed as CKD (≥stage 3b) or HF diagnosed by investigators, and as defined below:
- 1) CKD is diagnosed based on the CKD guidelines issued by the Japanese Society of Nephrologyxxix as being either or both of condition 1 and 2 for ≥3 months
- 1-i) Clear signs of kidney impairment based on the results of urinalysis, imaging, blood test, or biopsy. Presence of proteinuria, especially more than 0.15 g/gCr (albuminuria more than 30 mg/gCr).
Key exclusion criteria (12 listed)
- 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 (AKI)* within 6 months before enrolment
- Patients with acute heart failure within 3 months before enrolment
- Patients who received blood transfusion within 6 months before enrolment
- Patients with active malignancy or whose life expectancy is less than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient characteristics including socio-demographic variables, severity of disease and comorbidities
Time frame: 6 month
Health-Related Quality of Life
Time frame: 6 month
Serum Potassium
Time frame: 6 month
3 secondary outcomes
Nutritional status
Time frame: 6 month
Status of metabolic acidosis
Time frame: 6 month
Use of healthcare resource
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Derived from this study: PubMed 42837068Sada KE, Yamazaki H, Wakita T, Yamamoto Y, Wang J, Onishi Y, Hamada T, Ide R, Takeda M, Fukuhara S, Shibagaki Y. Quality of life in hyperkalemia: baseline analysis of a cohort study of management of hyperkalemia in patients with chronic kidney disease or heart failure in Japan. Clin Exp Nephrol. 2026 Oct 6. doi: 10.1007/s10157-026-02951-5. Online ahead of print.
- Derived from this study: PubMed 38101840Shibagaki Y, Yamazaki H, Wakita T, Ware JE, Wang J, Onishi Y, Yajima T, Sada KE, Yamamoto Y, Fukuhara S. Impact of treatment of hyperkalaemia on quality of life: design of a prospective observational cohort study of long-term management of hyperkalaemia in patients with chronic kidney disease or chronic heart failure in Japan. BMJ Open. 2023 Dec 14;13(12):e074090. doi: 10.1136/bmjopen-2023-074090.
- D9480R00027\_Redacted\_CSR\_synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials 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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Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
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A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
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Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
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Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkalemia, run by AstraZeneca at 32 sites in Japan.
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 12 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Japan. 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?
Patient characteristics including socio-demographic variables, severity of disease and comorbidities (time frame: 6 month). The study lists 3 primary outcomes in all. 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 NCT05297409, which also lists 2 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 8 Aug 2025.