Study of the influence of prolonged administration of topiroxostat and control of serum uric acid level on renal function in hyperuricemia patients

Study of the influence of prolonged administration of topiroxostat and control of serum uric acid level on renal function in hyperuricemia patients - Top real

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044642

Enrollment

Registered

2021-06-24

Start date

2021-07-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: [Inclusion criteria] 1) Patients taking topiroxostat continuously for at least 24 months (monotherapy/combination with a uric acid-lowering drug) 2) Patients aged 20 years or over at baseline 3) Patients with eGFR <60 at baseline (CKD Grade 3 or higher)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
(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).	—

Measure

Time frame

(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).

—

Countries

Japan

Contacts

Public ContactYuko Ishikawa

Satt Co., LTd Clinical research group

hua@sa-tt.co.jp03-5312-5026

Outcome results