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

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Phase II Study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220036

Enrollment

Registered

2022-04-23

Start date

2022-06-03

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 pediatric patients with or without gout

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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: 3xULN (upper limit of normal) or ALT: >3xULN -Systolic blood pressure: >= 180 mmHg or diastolic blood pressure: >= 110 mmHg etc.

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with serum urate <=6.0 mg/dL at the end of administration	—

Contacts

Public ContactDevelopment Department

FUJI YAKUHIN CO., LTD.

clinical-trials@fujiyakuhin.co.jp+81-48-644-3403

Outcome results

None listed

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