Assessment of efficacy and safety of dotinurad therapy for hyperuricemic patients with kidney dysfunction - DTN-CKD study

Wada Jun0 sites100 target enrollmentFebruary 22, 2022

Overview

Phase: 未知
Intervention: Not specified
Conditions: Patients with hyperuricemia whose renal function is in the GFR range of G1 to G4
Sponsor: Wada Jun
Enrollment: 100
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

February 22, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Wada Jun

•1\) Patients with hyperuricemia aged 20 years or older at the time of providing informed consent
•2\) Patients who have not received treatment with uricosuric drugs within 2 weeks prior to the observation start date
•3\) Patients with a serum uric acid level (untreated level) 8\.0 mg/dL or higher within 6 weeks prior to the observation start date
•4\) Patients with an estimated GFR (eGFR) 15 mL/min/1\.73m2 or higher within 6 weeks prior to the observation start date

•1\) Patients with acute gouty arthritis that has not subsided
•2\) Patients diagnosed with urolithiasis
•3\) Patients with secondary hyperuricemia (tumor lysis syndrome, etc.)
•4\) Patients with an AST or ALT of 100 IU/L or higher
•5\) Patients who are pregnant, likely to be pregnant, or breastfeeding
•6\) Patients with a history of hypersensitivity to the ingredients contained in dotinurad preparations
•7\) Patients who are judged as inappropriate for this study by the principal investigator or subinvestigator