type 2 diabetes mellitus, hyperkalemia
Conditions
Interventions
Sodium zirconium cyclosilicate (SZC) administration group:
Administer initial dose of SZC (10g/time, 3 times/day) for 2-3 days.
Then, administer maintainance dose of SZC (5-15g/time, once daily) til
C000597310, D004035
Sodium zirconium cyclosilicate, Diet Therapy
Sponsors
Hamaguchi Masahide
Fukui Michiaki
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 or urine protein/creatinine ratio is 3.5g/gCr or higher by spot urine test, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who are normokalaemic (3.5 mEq/L <= sK < 5.0 mEq/L) at visit 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of subjects who are normokalaemic (3.5 mEq/L <= sK < 5.0 mEq/L) at visit 4 2.Measurement of serum potassium at visit 7 | — |
Contacts
Public ContactMasahide Hamaguchi
University Hospital, Kyoto Prefectural University of Medicine
Outcome results
None listed