A Phase II Study of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout

JRCT ID: jRCT2031220036

Registered date:23/04/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hyperuricemic pediatric patients with or without gout
• Date of first enrollment: 03/06/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): FYU-981 is administered orally once daily starting with the initial dose of 0.25 or 0.5 mg/day, followed by the maintenance doses of 0.5 to 4 mg/day.

Outcome(s)

• Primary Outcome: Percentage of subjects with serum urate <=6.0 mg/dL at the end of administration

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 18age old
• Gender: Both

Include criteria

-Hyperuricemic pediatric patients with or without gout
-Serum urate level:
>= 7.0 mg/dL in patients with history of gout, or
>= 8.0 mg/dL in patients complicated with kidney disease, hypertension, diabetes, metabolic syndrome or ischemic heart disease, or
>= 9.0 mg/dL in patients with not applicable the above

Exclude criteria

-Gouty arthritis within two weeks before start of study treatment
-Renal overload type of hyperuricemia
-HbA1c: >= 9.0%
-Clinically significant cardiac, and hepatic disease
-Kidney calculi or clinically significant urinary calculi
-eGFR: < 30 mL/min/1.73 m^2
-AST: >3xULN (upper limit of normal) or ALT: >3xULN
-Systolic blood pressure: >= 180 mmHg or diastolic blood pressure: >= 110 mmHg
etc.

Related Information

• Primary Sponsor: Masahiko Fushimi
• Secondary Sponsor: Mochida Pharmaceutical Co., Ltd.