Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT04466969
Eligibility Criteria:
Inclusion Criteria:
* Outpatients aged ≥20 years
* Hyperkalemia patients defined as meeting either of the following criteria:
1. Having a history of S-K ≥5.1 mmol/L ≥2 times within 6 months before enrolment
2. Having a history of S-K ≥5.5 mmol/L once within 6 months before enrolment
3. 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
1. 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.
2. 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:
1. EF ≤40%
2. NYHA class II-IV
* Provision of signed, written, and detailed informed consent
* Signed written informed consent by themselves
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04466969
Study Brief:
Protocol Section:
NCT04466969