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

Hyperkalemia Clinical Trial

— HK registry  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05297409
• Other study ID #: D9480R00027
• Status: Active, not recruiting
• Start date: May 21, 2022
• Est. completion date: August 8, 2025

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 352
• Est. completion date: August 8, 2025
• Est. primary completion date: August 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Heart Failure
• Hyperkalemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Japan	Research Site	Azumino	Nagano
Japan	Research Site	Bunkyo	Tokyo
Japan	Research Site	Bunkyo	Tokyo
Japan	Research Site	Chikushino	Fukuoka
Japan	Research Site	Fukuyama	Hiroshima
Japan	Research Site	Hakusan	Ishikawa
Japan	Research Site	Hirosima-shi,Naka-ku	Hiroshima
Japan	Research Site	Iizuka-shi	Fukuoka
Japan	Research Site	Itabashi	Tokyo
Japan	Research Site	Itabashi	Tokyo
Japan	Research Site	Kagoshima
Japan	Research Site	Kanazawa	Ishikawa
Japan	Research Site	Kasugai	Aichi
Japan	Research Site	Kawasaki-shi,Kawasaki-ku	Kanagawa
Japan	Research Site	Kawasaki-shi,Miyamae-ku	Kanagawa
Japan	Research Site	Kitakyushu-shi	Fukuoka
Japan	Research Site	Kochi
Japan	Research Site	Kuwana	Mie
Japan	Research Site	Matsudo	Chiba
Japan	Research Site	Nagaoka	Niigata
Japan	Research Site	Nagaoka	Aichi
Japan	Research Site	Nagaoka	Aichi
Japan	Research Site	Osaka-shi,Kita-ku	Osaka
Japan	Research Site	Sakai	Osaka
Japan	Research Site	Sendai	Miyagi
Japan	Research Site	Shinjuku	Tokyo
Japan	Research Site	Shinjuku	Tokyo
Japan	Research Site	Shizuoka
Japan	Research Site	Takasaki	Gunma
Japan	Research Site	Takasaki	Gunma
Japan	Research Site	Tochigi
Japan	Research Site	Toyama
Japan	Research Site	Ueda	Nagano
Japan	Research Site	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Onset or worsening of HF, any rapid decline in kidney function, GI symptoms and peripheral edema		6 month
Primary	Patient characteristics including socio-demographic variables, severity of disease and comorbidities		6 month
Primary	Health-Related Quality of Life		6 month
Primary	Serum Potassium		6 month
Secondary	Nutritional status		6 month
Secondary	Status of metabolic acidosis		6 month
Secondary	Use of healthcare resource		6 month