Survey of dotinurad use in hyperuricemic patients with impaired renal function -A retrospective observational study-

Completed

• Conditions: Patients with hyperuricemia (renal function as eGFR category G1-G5)

• Registration Number: jRCT1051230149
• Lead Sponsor: Shimazu keiji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-21
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1)Of the patients who were prescribed dotinurad at Osaka Saiseikai Nakatsu Hospital (hereafter referred to as "this hospital") during the study period, those patients could be classified into eGFR categories G1 to G5 at the start of dotinurad administration. 2)Patients (of any gender) 20 years of age or older at the start of dotinurad treatment.

Exclusion Criteria

1)Patients who visited our clinic after being started on dotinurad at another medical institution (patients who were already taking dotinurad at the time of their first visit to our clinic). 2)Patients who indicated their intention not to participate by opting out.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients achieving a serum uric acid level of 6.0 mg/dL or less	12 months after the start of treatment	Percentage of patients achieving a serum uric acid level of 6.0 mg/dL or less at 12 months after the start of treatment with dotinurad

Secondary Outcome Measures

Name	Time	Method
Serum uric acid levels for each of the 12 months	12 months before and after the start of treatment with dotinurad	Serum uric acid levels for each of the 12 months before and after the start of treatment with dotinurad
Percentage of patients achieving serum uric acid levels of 6.0 mg/dL or less and 7.0 mg/dL or less	3, 6, and 12 months after the start of dotinurad treatment	Percentage of patients achieving serum uric acid levels of 6.0 mg/dL or less and 7.0 mg/dL or less (excluding assessments related to the primary endpoint)
eGFR and its change	3, 6, and 12 months after the start of dotinurad treatment	eGFR and its change (rate and amount)
eGFR at 12 months	12 months before and after the start of treatment with dotinurad	eGFR at 12 months before and after the start of treatment with dotinurad
Serum uric acid level and its change	3, 6, and 12 months after the start of dotinurad administration	Serum uric acid level and its change (rate and amount)