Inclusion criteria | Exclusion criteria |
---|---|
1. Men and women | 1. Uncontrolled diabetes mellitus; HbA1c: ≥8.0% (JDS) or ≥8.4% (NGSP) |
2. Age ≥20 years at informed consent | 2. Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg |
3. Patients with hyperuricemia; serum uric acid: 7.1-10.0Â mg/dL | 3. ALT or AST: greater than twice the upper limit of institutional reference range |
4. eGFR: 30–59 mL/min/1.73 m2 (CKD stages 3a and 3b) | 4. Change in serum creatinine level by more than 50% within 12 weeks before the confirmation of eligibility |
5. No history of gout | 5. Acute renal disease, nephrotic syndrome, other serious disease, dialysis, or renal transplantation |
6. Written informed consent for study enrollment obtained from the patient | 6. Complication or history of malignant tumor (not excluded from the study when the malignant tumor is not treated within 5 years and if there is no recurrence) |
 | 7. History of hypersensitivity to febuxostat |
 | 8. Intake of any one or more of the following drugs at the confirmation of eligibility: mercaptopurine hydrate, azathioprine, vidarabine, and didanosine |
 | 9. Intake of any one or more of the following urate-lowering drugs within 4 weeks before the confirmation of eligibility: allopurinol, benzbromarone, probenecid, bucolome, and febuxostat |
 | 10. Initiation of intake, dose modification, or discontinuation of intake of any one or more of the following drugs within 4 weeks before the confirmation of eligibility: losartan, fenofibrate, thiazide diuretics, and loop diuretics |
 | 11. Continuous intake of salicylic acid drugs, e.g., aspirin (the patient taking low-dose aspirin [≤324 mg/day] need not to be excluded from the study) |
 | 12. Hormone replacement therapy with estrogens |
 | 13. Pregnancy, nursing, or planed pregnancy during the study |
 | 14. Enrollment in other clinical trials within 24 weeks before providing informed consent |
 | 15. Ineligibility at the investigator’s discretion |