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

JRCT ID: jRCTs051230067

Registered date:11/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes mellitus, hyperkalemia
• Date of first enrollment: 10/11/2023
• Target sample size: 80
• Study type: Interventional

Intervention(s)

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 visit 7 (day 28-42), according to the SZC administration algorism.

Standard treatment group (potassium restriction diet instruction group):
Administer initial dose of SZC (10g/time, 3 times/day) for 2-3 days.
Then, discontinue administering the SZC, recieve instruction of potassium restriction diet by registered dietitian, according to the algorism of the instruction of potassium restriction diet, and conduct the potassium restriction diet til visit 7 (day 28-42).

Outcome(s)

• Primary Outcome: Proportion of subjects who are normokalaemic (3.5 mEq/L <= sK < 5.0 mEq/L) at visit 7

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hamaguchi Masahide
• Secondary Sponsor: Fukui Michiaki
• Source(s) of Monetary Support: AstraZeneca K.K.