Efficacy and safety of switching from febuxostat to dotinurad, a novel selective urate reabsorption inhibitor, in hyperuricemic patients with type 2 diabetes kidney disease - SWITCH SURI STUDY

Osonoi Takeshi0 个研究点目标入组 50 人开始时间: 2022年5月20日最近更新: 2024年4月1日

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•Patients who meet all of the following criteria are included in this study;
•1) Patients with serum uric acid levels of higher than 6.0 mg/dL and less than 10 mg/dL within 8 weeks prior to the date of consent
•2) Patients with type 2 diabetes mellitus
•3) Patients who have been receiving febuxostat at 20 mg/day for 3 months or longer and have not changed the usage or dosage of diabetes treatment drug from at least 8 weeks before the date of consent.
•4) Patients with renal dysfunction within 8 weeks prior to the consent date, with renal function of 30 or higher and less than 60 in eGFR (mL/min/1.73m2)
•5) Patients who have eGFR data since 6 months (plus or minus 2 months) before the date of consent
•6) Patients aged 20 years or older on the consent date (gender does not matter)
•7) Patients who give their written consent form to participate in the study

•Patients who fall into any of the following criteria at the consent date are excluded from participating in the study.
•1) Patients with severe renal dysfunction or end-stage renal failure on dialysis
•2) Patients after acute gouty arthritis or not subsided
•3) Patients with a history of the following diseases within 12 weeks prior to the date of consent; acute coronary syndrome, cerebrovascular accident, myocarditis, constrictive pericarditis, severe valvular disease
•4) Patients with hepatic dysfunction (AST or ALT 100 IU/L or higher)
•5) Patients diagnosed with urinary stones or patients with a history of urinary stones
•6) Patients who have been diagnosed with malignant tumors or who are suspected (In case patients who have not been treated with anticancer drugs for 1 year before the consent or whose doctor has determined that they will not continue to receive the treatment are included)
•7) Female patients who are pregnant, breastfeeding, or may be pregnant
•8) Patients receiving uricosuric drug, SGLT2 inhibitor, Losartan, Irbesartan or spherical adsorption charcoal within 8 weeks before the date of consent
•9) Patients who need a substitute
•10) Patients with a history of hypersensitivity to the components of Dotinurad
•11)Patients with other conditions that the investigator thinks unsuitable for participating in the study

发起方

Osonoi Takeshi