A study of DoTiNurad aiming to treat hyperuricemia with CKD

JRCT ID: jRCTs061210079

Registered date:22/02/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients with hyperuricemia whose renal function is in the GFR range of G1 to G4
• Date of first enrollment: 11/03/2022
• Target sample size: 100
• Study type: Interventional
• Intervention(s): The starting dose of dotinurad is 0.5 mg/day, once daily, and is titrated to a final dose of 2 mg/day up to a maximum of 4 mg/day.

Outcome(s)

• Primary Outcome: Percent change in serum uric acid levels at 24 weeks in G1/G2 and G3/G4 groups (non-inferiority)

Secondary Outcome

1) Change and percent change in serum uric acid levels and proportion of patients reaching the target level at 4, 8, 12, 24 weeks in G1/G2 and G3/G4 groups
2) Change and percent change in eGFR at 24 weeks in G1/G2 and G3/G4 groups
3) Change and percent change in serum uric acid levels and proportion of patients reaching the target level at 4, 8, 12, 24 weeks in eGFR classification-based 5 subgroups
4) Change and percent change in eGFR at 24 weeks in eGFR classification-based 5 subgroups
5) Change and percent change in serum uric acid levels by dose and proportion of patients reaching the target level
6) Change and percent change in serum uric acid levels by presence/absence and by cause of renal dysfunction and proportion of patients reaching the target level
7) Change and percent change in serum uric acid levels by age and proportion of patients reaching the target level
8) Dynamics of uric acid clearance/creatinine clearance ratio (CUA/CCr)
9) Dynamics of urine protein/creatinine ratio and urine albumin/creatinine ratio

Safety Outcomes
1) Adverse events
2) Liver function test results (AST, ALT, gamma-GT)
3) Urinary pH
4) Casual blood glucose level, HbA1c

Exploratory Outcomes
1) Investigation on the differences in patient backgrounds (at week 0) between patients who have reached the target level of serum uric acid control and those who have not
2) Investigation on the differences in information during the observation period, such as the dose of dotinurad and the incidence of gout, between patients who have reached the target level of serum uric acid control and those who have not

Key inclusion & exclusion criteria

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

Include criteria

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

Exclude criteria

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

Related Information

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