Status:
COMPLETED
Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study
Lead Sponsor:
AstraZeneca
Conditions:
Hyperkalemia
Eligibility:
All Genders
20+ years
Brief Summary
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 K...
Eligibility Criteria
Inclusion
- Outpatients aged ≥20 years
- Hyperkalemia patients defined as meeting either of the following criteria:
- Having a history of S-K ≥5.1 mmol/L ≥2 times within 6 months before enrolment
- Having a history of S-K ≥5.5 mmol/L once within 6 months before enrolment
- Currently treated by potassium binders for the treatment of hyperkalemia at enrolment
- Having been diagnosed as CKD (≥stage 3b) or HFrEF by investigators as defined below:
- 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
- Clear sign of kidney impairment based on urinalysis, imaging, blood test, or biopsy. Especially, existence of ≥0.15 g/gCr of proteinuria (≥30 mg/gCr of albuminuria) is important.
- GFR \<45 mL/min/1.73m2 Within the routine clinical practice, GFR is estimated by serum creatinine, gender, and age using following the formulation.
- 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:
- Stage 3b: 30 mL/min/1.73m2 ≤ eGFR \<45 mL/min/1.73m2
- Stage 4: 15 mL/min/1.73m2 ≤ eGFR \<30 mL/min/1.73m2
- Stage 5: eGFR \<15 mL/min/1.73m2
- Patients with HFrEF is enrolled if patients meet following criteria within 6 months:
- EF ≤40%
- NYHA class II-IV
- Provision of signed, written, and detailed informed consent
- Signed written informed consent by themselves
Exclusion
- 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 at enrolment •Patients who took blood transfusion or potassium supplements within 6 months before enrolment
- Active malignancy or life expectancy of less than 6 months.
- Patients who have GI disturbance/chronic diarrhoea/stoma, and investigators determine those affect significantly serum K level
- Patients who have autoimmune disorders, and investigators determine those affect significantly serum K level
- Patients whose lab data have suspicion for pseudohyperkalemia
- Patients who are pregnant, lactating, or planning to become pregnant
- Current participation in interventional studies and/or clinical trials
- Patients who, in the opinion of the investigators, would be unlikely to comply with self-assessments
Key Trial Info
Start Date :
July 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04466969
Start Date
July 31 2020
End Date
November 30 2020
Last Update
September 13 2021
Active Locations (5)
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1
Research Site
Nagoya, Aichi-ken, Japan, 457-8511
2
Research Site
Matsudoshi, Chiba, Japan, 271-0077
3
Research Site
Iizukashi, Fukuoka, Japan, 820-8505
4
Research Site
Sashimagun, Ibaraki, Japan, 306-0433