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

Not Applicable

• Conditions: Hyperuricemia

• Registration Number: JPRN-UMIN000039120
• Lead Sponsor: Koto Hospital

Brief Summary

After 12 months, sUA significantly decreased, but. sCr and eGFR showed slightly non-significant changes from the baseline. sCr were significantly increased during 6 months before topiroxostat administration (p < 0.001) but showed no significant change at 6 months after topiroxostat treatment (p = 0.682).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-10
• Study Completion: 2020-02-28
• Results First Posted: 2022-01-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in serum creatinine level from treatment initiation to the last assessment time point.

Secondary Outcome Measures

Name	Time	Method
(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.