An observational study in Hyperkalemia, sponsored by AstraZeneca. Completed at 5 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-09-13.
Sponsored by AstraZeneca · Observational
Overall study aim of this study is to analyse descriptive statistics of Patient-Reported Outcome(PROs) which will be used in the Hyperkalemia(HK) registry study in hyperkalemia patients with Chronic Kidney Disease(CKD) or Heart Failure(HF) to describe the practice patterns of hyperkalemia treatment in in clinical practice. Based on these assessments, this study will provide the information for the applicability of PRO measurements which will be used in the Hyperkalemia registry study to the study population, i.e. CKD and/or HF patients with hyperkalemia
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 146 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
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This study will include patients with hyperkalemia treated at outpatient clinics. Eligible patients will be screened through the regular visit to study sites in a consecutive manner. This study will be conducted in outpatient clinics in general hospitals. 150 hyperkalemia patients with CKD or HFrEF will be enrolled and assessed cross-sectionally.
After the written informed consent, subjects will be asked to complete the questionnaire-based survey.
Health-Related Quality of Life (HR-QoL), compliance to treatment with potassium binders, and other factors including age, sex, height, weight, smoking status, alcohol use and socio-economic status will be collected through the designated questionnaires. Information on disease status and on treatment patterns will be collected from physicians, and the latest results of laboratory tests will be collected from medical records (within 6 months before enrolment).
Hyperkalemia patients defined as meeting either of the following criteria:
CKD is diagnosed based on the guidelines of CKD issued by the Japanese Society of Nephrology (JSN, 2018) as being either or both of condition 1 and 2 for ≥3 months
eGFR creat (mL/min/1.73m2) = 194 x serum creatinine (mg/dL)-1.094 x age (years)-0.287 (for female patients, x 0.739)
≥Stage 3b CKD is diagnosed based on the following eGFR categories:
Patients with HFrEF is enrolled if patients meet following criteria within 6 months:
NYHA class II-IV
Exclusion Criteria:
Patients with HF with reduced Ejection Fraction (HFrEF) is enrolled if patients meet following criteria within 6 months: 1. Ejection Fraction ratio(EF) ≤40% 2. New York Heart Association(NYHA) class II-IV
CKD is diagnosed based on the following e Glomerular Filtration Rate (eGFR) categories: Stage 3b: 30 mL/min/1.73m2 ≤ eGFR \<45 mL/min/1.73m2
CKD is diagnosed based on the following eGFR categories: 15 mL/min/1.73m2 ≤ eGFR \<30 mL/min/1.73m2
CKD is diagnosed based on the following eGFR categories: eGFR \<15 mL/min/1.73m2
Patients who have been treated by Potassium Binders
Analyse descriptive statistics of PROs
The primary focus of this study is to analyse descriptive statistics of PROs which will be used in the Hyperkalemia registry. Information on demographics, medical history, treatment patterns, medication compliance, and self-reported questionnaire will be collected.
Time frame: 4weeks
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies 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.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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