HyperkalemiaHKRegistrypiloNCT04466969
Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study
An observational study of Hyperkalemia, run by AstraZeneca at 5 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperkalemia
- Type of treatment
- Injection or infusion
- How many people
- 146 participants
- Where
- 5 sitesJapan
- Study dates
- 31 Jul 2020to 30 Nov 2020
- 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: 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).
Who may be able to join
- Outpatients aged ≥20 years
- Hyperkalemia patients defined as meeting either of the following criteria:
- Having a history of S-K ≥5.1 mmol/L ≥2 times within 6 months before enrolment
- Having a history of S-K ≥5.5 mmol/L once within 6 months before enrolment
- 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:
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- 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
- 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.
- 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:
- EF ≤40%
- NYHA class II-IV
- Provision of signed, written, and detailed informed consent
- Signed written informed consent by themselves
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 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Research Site
Iizukashi, Fukuoka, 820-8505
Research Site
Matsudoshi, Chiba, 271-0077
Research Site
Nagoya, Aichi-ken, 457-8511
Research Site
Sashimagun, Ibaraki, 306-0433
Research Site
Tsuchiurashi, Ibaraki, 300-0028
About this study
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
- 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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start31 Jul 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466969
- Sponsor's protocol ID
- D9480R00030
- Acronym
- HKRegistrypilo
- Status last verified
- Sep 2021
- First submitted
- 7 Jul 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study
- ClinicalTrials.gov ID
- NCT04466969
- Acronym / sponsor ID
- HKRegistrypilo / D9480R00030
- Conditions
- Hyperkalemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 10 Jul 2020 (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.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (19 listed)
- Outpatients aged ≥20 years
- Hyperkalemia patients defined as meeting either of the following criteria:
- 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
- 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.
Key exclusion criteria (9 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 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
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
Analyse descriptive statistics of PROs
Time frame: 4weeks
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.
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 13 Sep 2021.
- 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/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.
Related trials for Hyperkalemia
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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.
5 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 5 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 19 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: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Analyse descriptive statistics of PROs (time frame: 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2021.