An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure

NCT05297409 | Completed

• 1 other identifier: D9480R00027
• Study Type: observational
• Target: 352
• Locations: 1 country
• Sites: 32

Brief 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.

Conditions

Hyperkalemia

Outcome Measures

Primary Outcomes (3)

• Patient characteristics including socio-demographic variables, severity of disease and comorbidities

  6 month

• Health-Related Quality of Life

  6 month

• Serum Potassium

  6 month

Secondary Outcomes (3)

• Nutritional status

  6 month

• Status of metabolic acidosis

  6 month

• Use of healthcare resource

  6 month

Other Outcomes (1)

• Onset or worsening of HF, any rapid decline in kidney function, GI symptoms and peripheral edema

  6 month

Study Arms (2)

Hyperkalemia patient with Chronic kidney disease

hyperkalemia patient with heart failure

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Patients with hyperkalemia who meet the following criteria:
• \) 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:
• \) 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
• 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).
• ii) GFR \<45 mL/min/1.73m2
• \) 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (32)

Research Site

Kasugai, Aichi-ken, 486-8510, Japan

Location

Research Site

Nagaoka, Aichi-ken, 457-8511, Japan

Location

Research Site

Nagaoka, Aichi-ken, 460-0001, Japan

Location

Research Site

Matsudo, Chiba, 271-0077, Japan

Location

Research Site

Chikushino-shi, Fukuoka, 818-0058, Japan

Location

Research Site

Iizuka-shi, Fukuoka, 820-8505, Japan

Location

Research Site

Kitakyushu-shi, Fukuoka, 802-8555, Japan

Location

Research Site

Takasaki, Gunma, 370-0001, Japan

Location

Research Site

Takasaki, Gunma, 370-8537, Japan

Location

Research Site

Fukuyama, Hiroshima, 729-0104, Japan

Location

Research Site

Hirosima-shi,Naka-ku, Hiroshima, 730-8518, Japan

Location

Research Site

Hakusan, Ishikawa-ken, 924-8588, Japan

Location

Research Site

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Research Site

Kawasaki-shi,Kawasaki-ku, Kanagawa, 210-0852, Japan

Location

Research Site

Kawasaki-shi,Miyamae-ku, Kanagawa, 216-8511, Japan

Location

Research Site

Kuwana, Mie-ken, 511-0061, Japan

Location

Research Site

Sendai, Miyagi, 982-8502, Japan

Location

Research Site

Azumino, Nagano, 399-8292, Japan

Location

Research Site

Ueda, Nagano, 386-8610, Japan

Location

Research Site

Nagaoka, Niigata, 940-8653, Japan

Location

Research Site

Osaka-shi,Kita-ku, Osaka, 530-0012, Japan

Location

Research Site

Sakai, Osaka, 593-8304, Japan

Location

Research Site

Bunkyo, Tokyo, 113-8431, Japan

Location

Research Site

Bunkyo, Tokyo, 113-8519, Japan

Location

Research Site

tabashi City, Tokyo, 173-0032, Japan

Location

Research Site

tabashi City, Tokyo, 173-8610, Japan

Location

Research Site

Kagoshima, 890-0075, Japan

Location

Research Site

Kochi, 781-0082, Japan

Location

Research Site

Shizuoka, 410-2295, Japan

Location

Research Site

Tochigi, 321-0293, Japan

Location

Research Site

Toyama, 939-8511, Japan

Location

Research Site

Yamagata, 990-8533, Japan

Location

Related Publications (1)

• 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.

  PMID: 38101840 DERIVED

Related Links

• D9480R00027\_Redacted\_CSR\_synopsis

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: May 21, 2022
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: 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.

Locations

JP (32)