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

JRCT ID: jRCT1051230149

Registered date:21/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with hyperuricemia (renal function as eGFR category G1-G5)
• Date of first enrollment: 21/12/2023
• Target sample size: 500
• Study type: Observational

Outcome(s)

• Primary Outcome: 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

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Shimazu keiji
• Source(s) of Monetary Support: Fuji Yakuhin Co.,Ltd,MOCHIDA PHARMACEUTICAL CO.,LTD.