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

JRCT ID: jRCTs031220080

Registered date:20/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: diabetic kidney disease, Hyperuricemia
• Date of first enrollment: 20/05/2022
• Target sample size: 50
• Study type: Interventional
• Intervention(s): The study subjects started oral administration of Uris Tablets 0.5 mg once daily within 1 week from the end of the baseline test. The uric acid level exceeded 6 mg/dL even after administration for 2 weeks or more, the dose of Uris tablets should be gradually increased (up to 4 mg) at the observation point or other regular visits. The observation period should be continued for up to 24 weeks.

Outcome(s)

• Primary Outcome: Proportion of patients who achieve serum uric acid level of 6 mg/dL or less at week 24 after Dotinurad administration

Secondary Outcome

The following items at observation points 4, 12, 24 weeks from baseline
1. Change and percent change in serum uric acid level
2. Change and percent change in plasma indoxyl sulfate
3. Change and percent change in renal function biomarkers; eGFR, eGFR slope, serum creatinine, urinary albumin, and urinary creatinine (measured by spot urine. values are collected by urinary creatinine.)
4. Change and percent change in the dose of the study drug

Key inclusion & exclusion criteria

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

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Osonoi Takeshi
• Source(s) of Monetary Support: FUJI YAKUHIN CO., LTD,MOCHIDA PHARMACEUTICAL CO., LTD.