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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperkalemia patient with Chronic kidney disease | |||
| hyperkalemia patient with heart failure |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient characteristics including socio-demographic variables, severity of disease and comorbidities | 6 month | |
| Health-Related Quality of Life | 6 month | |
| Serum Potassium | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status | 6 month | |
| Status of metabolic acidosis | 6 month | |
| Use of healthcare resource |
| Measure | Description | Time Frame |
|---|---|---|
| Onset or worsening of HF, any rapid decline in kidney function, GI symptoms and peripheral edema | 6 month |
Inclusion Criteria:
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
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Kasugai | Aichi-ken | 486-8510 | Japan | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38101840 | Derived | 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. |
| Label | URL |
|---|---|
| D9480R00027\_Redacted\_CSR\_synopsis | View source |
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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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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| 6 month |
| Nagaoka |
| Aichi-ken |
| 457-8511 |
| Japan |
| Research Site | Nagaoka | Aichi-ken | 460-0001 | Japan |
| Research Site | Matsudo | Chiba | 271-0077 | Japan |
| Research Site | Chikushino-shi | Fukuoka | 818-0058 | Japan |
| Research Site | Iizuka-shi | Fukuoka | 820-8505 | Japan |
| Research Site | Kitakyushu-shi | Fukuoka | 802-8555 | Japan |
| Research Site | Takasaki | Gunma | 370-0001 | Japan |
| Research Site | Takasaki | Gunma | 370-8537 | Japan |
| Research Site | Fukuyama | Hiroshima | 729-0104 | Japan |
| Research Site | Hirosima-shi,Naka-ku | Hiroshima | 730-8518 | Japan |
| Research Site | Hakusan | Ishikawa-ken | 924-8588 | Japan |
| Research Site | Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Research Site | Kawasaki-shi,Kawasaki-ku | Kanagawa | 210-0852 | Japan |
| Research Site | Kawasaki-shi,Miyamae-ku | Kanagawa | 216-8511 | Japan |
| Research Site | Kuwana | Mie-ken | 511-0061 | Japan |
| Research Site | Sendai | Miyagi | 982-8502 | Japan |
| Research Site | Azumino | Nagano | 399-8292 | Japan |
| Research Site | Ueda | Nagano | 386-8610 | Japan |
| Research Site | Nagaoka | Niigata | 940-8653 | Japan |
| Research Site | Osaka-shi,Kita-ku | Osaka | 530-0012 | Japan |
| Research Site | Sakai | Osaka | 593-8304 | Japan |
| Research Site | Bunkyo | Tokyo | 113-8431 | Japan |
| Research Site | Bunkyo | Tokyo | 113-8519 | Japan |
| Research Site | tabashi City | Tokyo | 173-0032 | Japan |
| Research Site | tabashi City | Tokyo | 173-8610 | Japan |
| Research Site | Kagoshima | 890-0075 | Japan |
| Research Site | Kochi | 781-0082 | Japan |
| Research Site | Shizuoka | 410-2295 | Japan |
| Research Site | Tochigi | 321-0293 | Japan |
| Research Site | Toyama | 939-8511 | Japan |
| Research Site | Yamagata | 990-8533 | Japan |
| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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