Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat on serum uric acid, endothelial function and markers for kidney injury

Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat on serum uric acid, endothelial function and markers for kidney injury - Prospective, randomized, open-label, clinical trial comparing the effects of topiroxostat and febuxostat.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026765

Enrollment

Registered

2017-03-30

Start date

2017-03-30

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

Hyperuremia

Interventions

Topiroxostat 40-160mg /day for 12 weeks &gt

Febuxostat 10-40mg /day for 12 weeks Febuxostat 10-40mg/day for 12 weeks &gt

Topiroxostat 40-160mg/day for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Poor-controlled hyperuricemia despite adequate lifestyle improvement for 8 weeks.(UA>8mg/dl) 2) 20 years of age or more 3) female or male 4) outpatients 5) eGFR>30ml/min./1.73m2 6) Subjects who can get the consent to join this study

Exclusion criteria

Exclusion criteria: 1) Subjects who has a history of allergy to topiroxostat or febuxostat. 2) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 3) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 4) Subjects who has already taken mercaptopurine hydrate, azathioprine, vidarabine, didanosine. 5) Subjects whose doctor in charge do not agree to join the trial 6) Subjects who has past medical histories of active hemorrhage, ulcer, stroke, optical hemorrhage, hemorrhagic tendency.

Design outcomes

Primary

Measure	Time frame
Flow-mediated vasodilation in forearm, serum level of uric acid, marker of early-staged kidney diseases 12 weeks after administration	—

Secondary

Measure	Time frame
Serum level of lipid, glucose, HbA1c and liver function, Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), 12 weeks after administration	—

Countries

Japan

Contacts

Public ContactMisa Ito

Self-Defense Forces Fuji Hospital Department of Internal Medicine

jumpimjumpim@gmail.com0550-75-2311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026