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Effects on cardiac, renal, and vascular endothelial markers after switching to topiroxostat from febuxostat treatment among IGT patients

Effects on cardiac, renal, and vascular endothelial markers after switching to topiroxostat from febuxostat treatment among IGT patients - Effects on cardiac, renal, and vascular endothelial markers after switching to topiroxostat from febuxostat treatment among IGT patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018139
Enrollment
100
Registered
2015-06-30
Start date
2015-07-13
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

Hyperuricemic patients complicated with impaired glucose tolerance (IGT)

Interventions

1. Study period: 4 weeks before intervention + interventional treatment for 24 weeks 2. Prescription of topiroxostat is based on the amount of febuxostat administered 3. Amount of topiroxostat is
=4.0mg/dL, and &lt
=6.0 mg/dL 4. Maximum amount of topiroxostat administration is 80mg x 2, and the minimum amount is 20mg x 1

Sponsors

Diabetes and Lifestyle Center, Tomonaga Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are included: 1. Being diagnosed as having urarthritis or hyperuricemia at the time of giving their consent 2. Have treated urarthritis or hyperuricemia with topiroxostat for 12 weeks or longer until giving their written consent form 3. Diagnosed as IGT, and currently on drug treatment 4. Have continued diet and exercise therapy for at least 8 weeks until giving written consent form 5. Can provide written consent form by patients themselves 6. Outpatients (who have no plan to be admitted into the hospital)

Exclusion criteria

Exclusion criteria: Patients who fall into any of the following conditions are excluded: 1. Have a history of hypersensitiveness to topiroxostat, febuxostat, or allopurinol 2. Currently on mercaptopurine hydrate (including those who plan to use) 3. Currently on azathioprine (including those who plan to use) 4. Cancer-carrying (excepts for those completely cured) 5. ALT or AST value is twice higher than the standard value set by each institution 6. Complicated with chronic hepatitis (type B or C) and classified as active 7. Complicated with hepatic cirrhosis 8. Other conditions that may be judged by a (responsible) investigator to be inappropriate to this study

Design outcomes

Primary

MeasureTime frame
1. change of L-FABP value 2. change of UACR value 3. change of serum uric acid value 4. change of BNP value 5. change of eGFR value 6. change of HbA1c value 7. change of HOMA-IR value 8. change of hsCRP value 9. amount of change in plasma XOR activity 10. rate of urarthritis (side effect) 11. rate of abnormal test results of liver function (side effect) 12. rate of other adverse events

Countries

Japan

Contacts

Public ContactOsamu Tomonaga

Diabetes and Lifestyle Center, Tomonaga Clinic Internal Medicine

boss@tomonaga-clinic.com03-3351-0032

Outcome results

None listed

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