Patients with CKD and hyperuricemia
Conditions
Interventions
Group A: Intensive therapy group with Topiroxostat Target serum uric acid level: 4.0 mg/dL to 5.0 mg/dL The treatment period: 12 months Maximum usage of Topiroxostat is 160 mg per day.
Group B: Sta
Sponsors
Nara medical Univ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Including criteria 1.Patinets aged 20 years and older 2.Stage 3 CKD patients(30<=eGFR<60 ml/min/1.73m2)whose urinary protein excretion is less than 0.5g/gCre or urinary albumin excretion is less than 300mg/gCre. 3.Patients whose serum uric acid level is higher than 8.0 mg/dl, or patients with allopurinol and/or benzbromarone whose serum uric acid level is higher than 7.0 mg/dl
Exclusion criteria
Exclusion criteria: Excluding criteria 1. History of hypersensitivity to topiroxostat 2. Being treated with either febuxostat or topiraxostat 3. History of repeated gouty arthritis attack 4. History of attacks of urinary stone within 6 months 5. Obstructive urinary tract disorders 6. Primary or secondary hyperuricemia (congenital myogenic hyperuricemia, hematopoietic tumor, solid tumor, secondary polycythemia, hemolytic anemia, tumor lysis syndrome, rhabdomyolysis, multiple sclerosis, multiple juvenile gout nephropathy, polycystic kidney etc.) 7. active malignancy 8. Severe hepatic dysfunctions (transaminase >= 100 IU / L) 9. Poorly controlled diabetes mellitus (HbA1c> 8.4%) 10. Severe hypertension (sBP >= 180 mm Hg or dBP >= 110 mm Hg) 11. Pregnant patients / lactating patients, female patients who wish to become pregnant during the study 12. Being or supposed to be under medication with mercaptopurine hydrate and azathioprine that are contraindicated with topiroxostat. 13. Any antihypertensive drugs have been changed within a month or will be changed after the trial registration 14. Currently participating in other intervention studies (no restrictions are applied to participation in other observational study) 15. Suffering acute illnesses that may affect the effectiveness and safety until the main registration after primary registration 16. The participation to this study is judged inappropriate by the attending physicianto
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in urinary albumin-to-creatinine ratio | — |
Countries
Japan
Contacts
Public ContactMasato Kasahara
Nara Medical University Hospital Institute for Clinical and Translational Science
Outcome results
None listed