Efficacy and safety of FYX-051 in hyperuricemic patients with moderate renal insufficiency
Phase 3
- Conditions
- Hyperuricemia and Gout
- Registration Number
- JPRN-jRCT2080221136
- Lead Sponsor
- SANWA KAGAKU KENKYUSHO Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with hyperuricemia with the following serum urate level:
- Serum urate level of >= 7.0mg/dL in patients with history of gout, or
- Serum urate level of >= 8.0mg/dL in other patient
Patients with moderate renal insufficiency
- eGFR level of >= 30mL/min/1.73m2, but < 60mL/min/1.73m2
Exclusion Criteria
Patients with gouty arthritis within two weeks before start of study treatment
Patients with secondary hyperuricemia
Patients with, or a history of, clinically significant cardiac, hematologic and hepatic disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy and Safety
- Secondary Outcome Measures
Name Time Method