An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure
NCT ID: NCT05297409
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
352 participants
OBSERVATIONAL
2022-05-21
2024-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hyperkalemia patient with Chronic kidney disease
No interventions assigned to this group
hyperkalemia patient with heart failure
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Kasugai, Aichi-ken, Japan
Research Site
Nagaoka, Aichi-ken, Japan
Research Site
Nagaoka, Aichi-ken, Japan
Research Site
Matsudo, Chiba, Japan
Research Site
Chikushino-shi, Fukuoka, Japan
Research Site
Iizuka-shi, Fukuoka, Japan
Research Site
Kitakyushu-shi, Fukuoka, Japan
Research Site
Takasaki, Gunma, Japan
Research Site
Takasaki, Gunma, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Hirosima-shi,Naka-ku, Hiroshima, Japan
Research Site
Hakusan, Ishikawa-ken, Japan
Research Site
Kanazawa, Ishikawa-ken, Japan
Research Site
Kawasaki-shi,Kawasaki-ku, Kanagawa, Japan
Research Site
Kawasaki-shi,Miyamae-ku, Kanagawa, Japan
Research Site
Kuwana, Mie-ken, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Azumino, Nagano, Japan
Research Site
Ueda, Nagano, Japan
Research Site
Nagaoka, Niigata, Japan
Research Site
Osaka-shi,Kita-ku, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Bunkyo, Tokyo, Japan
Research Site
Bunkyo, Tokyo, Japan
Research Site
tabashi City, Tokyo, Japan
Research Site
tabashi City, Tokyo, Japan
Research Site
Kagoshima, , Japan
Research Site
Kochi, , Japan
Research Site
Shizuoka, , Japan
Research Site
Tochigi, , Japan
Research Site
Toyama, , Japan
Research Site
Yamagata, , Japan
Countries
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References
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Shibagaki 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.
Related Links
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Other Identifiers
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D9480R00027
Identifier Type: -
Identifier Source: org_study_id
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