Evaluating Safety and efficacy in retrospective ANAlysis after switching Drug to topiroxostat Among patients with hyperuricemia study

Evaluating Safety and efficacy in retrospective ANAlysis after switching Drug to topiroxostat Among patients with hyperuricemia study - Evaluating Safety and efficacy in retrospective ANAlysis after switching Drug to topiroxostat Among patients with hyperuricemia study (SANADA study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023584

Enrollment

200

Registered

2016-08-10

Start date

2016-07-04

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

gouty or hyperuricemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. Patients undergone treatment for either gout or hyperuricemia in the clinic from January 2015 to March 2016 2. Patients newly started topiroxostat treatment, or switched to topiroxostat treatment from allopurinol or febuxostat and continued the topiroxostat for at least 12 weeks 3. Patients at age of 20 or older when giving their consent 4. Patients who can provide their consent in a written form

Exclusion criteria

Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study. 1. Patients who is hypersensitive to topiroxostat, febuxostat, or allopurinol 2. Dehydrated patients or patients with impairment in drinking water 3. Patients with rheumatic disease 4. Patients with COPD 5. Patients with idiopathic thrombocytopenic purpura (ITP) 6. Patients taking pyrazinamide or ethambutol while giving their samples 7. Patients taking mizoribine or cyclosporine while giving their samples 8. Patients taking mercaptopurine hydrate, or azathioprine while giving their samples 9. Patients taking xanthine-based medicine while giving their samples 10. Patients taking non-steroidal anti-inflammatory/NSAIDs drug while giving their samples 11. Other conditions that a physician thinks inappropriate to participate in the study

Design outcomes

Primary

Measure	Time frame
Changed amount in L-FABP values from baseline to the week 24	—

Secondary

Measure	Time frame
1. Changed amount and rate from baseline to the week 24 in the values listed below: * Marker of renal function, such as albumin/creatinine ratio (ACR), beta 2-microglobulin (beta 2-MG) , urinary N/acetyl/beta/D/glucosaminidase (NAG) , cystatine C, and eGFR * BNP * remnant-like lipoprotein particle cholesterol (RLPC) * hs-CRP * Xanthine oxidoreductase * Xanthine * Hypoxanthin * IMT * PWV * Other, vital, general blood test, urine test 2. Incidence rate of AE, such as gouty arthritis	—

Measure

Time frame

1. Changed amount and rate from baseline to the week 24 in the values listed below: * Marker of renal function, such as albumin/creatinine ratio (ACR), beta 2-microglobulin (beta 2-MG) , urinary N/acetyl/beta/D/glucosaminidase (NAG) , cystatine C, and eGFR * BNP * remnant-like lipoprotein particle cholesterol (RLPC) * hs-CRP * Xanthine oxidoreductase * Xanthine * Hypoxanthin * IMT * PWV * Other, vital, general blood test, urine test 2. Incidence rate of AE, such as gouty arthritis

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Countries

Japan

Contacts

Public ContactHiroki Takayama

Soiken Inc. Clinical Study Support Division

takayama@soiken.com03-3295-1350

Outcome results