JPRN-jRCTs051230067RecruitingUnknown
Sodium zirconium cyclosilicate non-Inferiority on hyperkalemia (Level of serum potassium) VErsus potassium Restricted diet in Subjects with type 2 diabetes mellitus; multicenter, open-label, randomized controlled, Two-Arm Research - SILVER-STAR study
Hamaguchi Masahide0 sites80 target enrollmentStarted: July 11, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to < 90age old (—)
- Sex
- All
Inclusion Criteria
- •Patients who meet all of the following criteria are included in this study:
- •1. patients with type 2diabetes mellitus*
- •2. patients with serum potassium of 5.0mEq/L or higher and 6.0mEq/L or less at giving their consent
- •3. male and female aged 20 years or older and younger than 90 years at giving their consent
- •4. patients who provide their consent in a written form
- •*Type 2 diabetes mellitus is diagnosed according to the diabetes mellitus treatment guideline 2019 released from the Japan Diabetes Society
Exclusion Criteria
- •Patients who fall into any of the following criteria are excluded from participating in the study.
- •1. patients who were treated by other conventional pharmacotherapy to the hyperkalemia within 7 days before giving their consent
- •2. patients who are diagnosed as acute kidney injury according to the Kidney Disease: Improving Global Outcomes criteria
- •3. patients whose eGFR is less than 15ml/min/1.72m2, patients whose serum creatinine is 3.5mg/dL or higher, or patients who are treated by dialysis
- •4. patients with heart failure (NYHA classification III or IV)
- •5. patients whose activities of daily living (ADL) is PS2 or higher, and with aged 65 years or older
- •6. patients with history of QT prolongation related to other pharmacotherapy, and with history of discontinuation of the pharmacotherapy
- •7. patients with congenital long QT syndrome
- •8. patients with QTc (f) of longer than 550msec
- •9. patients with pacemaker
- •10. patients with symptomatic or uncontrolled atrial fibrillation despite of medical treatment, or patients with asymptomatic sustained ventricular tachycardia (patients with atrial fibrillation which is well-controlled by pharmacotherapy can be included in this study)
- •11. patients who are pregnant or planning to be pregnant
- •12. patients who are treated for malignant neoplasm
- •13. patients with moderate to severe anemia (Hb is 10g/dL or less) whose primary disease is other than diabetic nephropathy
- •14. patients with hypoalbuminemia (serum albumin is 3.5g/dL or less) whose primary disease is other than diabetic nephropathy
- •15. patients with nephrotic syndrome (urine protein is 3.5g/day or more, and serum albumin is 3.0g/dL or less) whose primary disease is other than diabetic nephropathy
- •16. patients with poor adherence judged by the attending physician
- •17. patients who require legal representative
- •18. patients with other conditions that the attending physician thinks inappropriate to administer sodium zirconium cyclosilicate
Investigators
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