Study on effect of topiroxostat administration on serum creatinine level in patients with hyperuricemia.

Study on effect of topiroxostat administration on serum creatinine level in patients with hyperuricemia. - Study on effect of topiroxostat administration on serum creatinine level in patients with hyperuricemia.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039120

Enrollment

100

Registered

2020-01-10

Start date

2020-01-10

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: (1) Patient took topiroxostat for at least 1 year (2) Patient aged at least 20 years on treatment initiation date

Exclusion criteria

Exclusion criteria: (1) Patient has serious liver or kidney disease at initiation of topiroxostat treatment (2) Patient undergoing hemodialysis or has undergone kidney transplantation at initiation of topiroxostat treatment (3) Patient has comorbid malignancy at initiation of topiroxostat treatment (4) Patient coadministered another urate-lowering drug at initiation of topiroxostat treatment (5) Patient deemed unsuitable for participation in this research by the investigator

Design outcomes

Primary

Measure	Time frame
Change in serum creatinine level from treatment initiation to the last assessment time point.	—

Secondary

Measure	Time frame
(1) Serum creatinine level 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (2) Serum uric acid level 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (3) BUN 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (4) eGFR 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (5) AST, ALT Change from treatment initiation at each time point (6) TG, HDL-C, LDL-C Change from treatment initiation at each time point (7) HbA1c Change from treatment initiation at each time point (8) Safety assessment The occurrence of adverse events and adverse drug reactions during the topiroxostat treatment period will be assessed.	—

Measure

Time frame

(1) Serum creatinine level 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (2) Serum uric acid level 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (3) BUN 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (4) eGFR 1) Change from baseline after administration of topiroxostat 2) Change from treatment initiation at each time point (5) AST, ALT Change from treatment initiation at each time point (6) TG, HDL-C, LDL-C Change from treatment initiation at each time point (7) HbA1c Change from treatment initiation at each time point (8) Safety assessment The occurrence of adverse events and adverse drug reactions during the topiroxostat treatment period will be assessed.

—

Countries

Japan

Contacts

Public ContactKousaku Kawada

Satt Co.,Ltd Project Management-Team

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

Outcome results