Clinical trial NCT05297409: An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure
Official title: Hyperkalemia Registry An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperkalemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-03-28
Enrollment: 352
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient characteristics including socio-demographic variables, severity of disease and comorbidities
timeFrame: 6 month
measure: Health-Related Quality of Life
timeFrame: 6 month
measure: Serum Potassium
timeFrame: 6 month
Secondary outcomes:
measure: Nutritional status
timeFrame: 6 month
measure: Status of metabolic acidosis
timeFrame: 6 month
measure: Use of healthcare resource
timeFrame: 6 month
Other outcomes:
measure: Onset or worsening of HF, any rapid decline in kidney function, GI symptoms and peripheral edema
timeFrame: 6 month
Locations:
city: Kasugai
country: Japan
facility: Research Site
state: Aichi
city: Nagaoka
country: Japan
facility: Research Site
state: Aichi
city: Nagaoka
country: Japan
facility: Research Site
state: Aichi
city: Matsudo
country: Japan
facility: Research Site
state: Chiba
city: Chikushino
country: Japan
facility: Research Site
state: Fukuoka
city: Iizuka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Takasaki
country: Japan
facility: Research Site
state: Gunma
city: Takasaki
country: Japan
facility: Research Site
state: Gunma
city: Fukuyama
country: Japan
facility: Research Site
state: Hiroshima
city: Hirosima-shi,Naka-ku
country: Japan
facility: Research Site
state: Hiroshima
city: Hakusan
country: Japan
facility: Research Site
state: Ishikawa
city: Kanazawa
country: Japan
facility: Research Site
state: Ishikawa
city: Kawasaki-shi,Kawasaki-ku
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki-shi,Miyamae-ku
country: Japan
facility: Research Site
state: Kanagawa
city: Kuwana
country: Japan
facility: Research Site
state: Mie
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Azumino
country: Japan
facility: Research Site
state: Nagano
city: Ueda
country: Japan
facility: Research Site
state: Nagano
city: Nagaoka
country: Japan
facility: Research Site
state: Niigata
city: Osaka-shi,Kita-ku
country: Japan
facility: Research Site
state: Osaka
city: Sakai
country: Japan
facility: Research Site
state: Osaka
city: Bunkyo
country: Japan
facility: Research Site
state: Tokyo
city: Bunkyo
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi
country: Japan
facility: Research Site
state: Tokyo
city: Kagoshima
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
Study officials:
References: