Study of the influence of prolonged administration of topiroxostat and control of serum uric acid level on renal function in hyperuricemia patients
Not Applicable
- Conditions
- Hyperuricemia
- Registration Number
- JPRN-UMIN000044642
- Lead Sponsor
- Medical corporation jyosuikai Shimada hospital Hidetaka Shimada
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
Not provided
Exclusion Criteria
[Exclusion criteria] (1) Patients with AST or ALT 100 IU/L or higher at the start of topiroxostat treatment (2) Patients with eGFR < 30 at the start of topiroxostat treatment (3) Patients receiving hemodialysis at the start of topiroxostat treatment or those who underwent kidney transplantation (4) Patients with viral hepatitis, chronic liver disease, or malignancy at the start of topiroxostat treatment (5) Patients considered inappropriate for participation in the study by the investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients will be divided into 2 groups: Low group (patients with a mean uric acid level of 6 mg/dl or less for 6 months or longer at 12 months or later) and High group (those other than the above). The change in eGFR from baseline to the final evaluation at 24 months will be compared.
- Secondary Outcome Measures
Name Time Method (1)Uric acid level 1)Change from baseline to 24 months(by GFR category*) (2)Serum creatinine level 1)Change from baseline to 24 months 2)Doubling rate from baseline to 24 months(by uric acid level*) (3)eGFR 1)Change from baseline to 24 months 2)Change from baseline to 24 months(by GFR category) 3)30% reduction rate from baseline to 24 months(by uric acid level) *By GFR category: GFR category at baseline(G3a, G3b, G4, G5) *By uric acid level: The uric acid value at baseline is divided into 6 groups(<6.0,6.0-6.9,7.0-7.9,8.0-8.9,9.0-9.9,>10).