A study of DoTiNurad aiming to treat hyperuricemia with CKD (DTN-CKD study)

Completed

• Conditions: Patients with hyperuricemia whose renal function is in the GFR range of G1 to G4

• Registration Number: jRCTs061210079

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-22
• Study Start: 2022-03-11
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Percent change in serum uric acid levels at 24 weeks in G1/G2 and G3/G4 groups (non-inferiority)

Secondary Outcome Measures

Name	Time	Method
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, 8, 12, 24 weeks	Change and percent change in serum uric acid levels and proportion of patients reaching the target level
Change and percent change in eGFR at 24 weeks in eGFR classification-based 5 subgroups	24 weeks	Change and percent change in eGFR
Change and percent change in serum uric acid levels by dose and proportion of patients reaching the target level		Change and percent change in serum uric acid levels and proportion of patients reaching the target level
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		Change and percent change in serum uric acid levels and proportion of patients reaching the target level
Change and percent change in serum uric acid levels by age and proportion of patients reaching the target level		Change and percent change in serum uric acid levels and proportion of patients reaching the target level
Dynamics of uric acid clearance/creatinine clearance ratio (CUA/CCr)		Dynamics of uric acid clearance/creatinine clearance ratio
Dynamics of urine protein/creatinine ratio and urine albumin/creatinine ratio		Dynamics of urine protein/creatinine ratio and urine albumin/creatinine ratio
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	week 0	Investigation on the differences in patient backgrounds between patients who have reached the target level of serum uric acid control and those who have not
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	observation period	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
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	4, 8, 12, 24 weeks	Change and percent change in serum uric acid levels and proportion of patients reaching the target level
Change and percent change in eGFR at 24 weeks in G1/G2 and G3/G4 groups	24 weeks	Change and percent change in eGFR
Adverse events		Adverse events
Liver function test results (AST, ALT, gamma-GT)		Liver function test results (AST, ALT, gamma-GT)
Urinary pH		Urinary pH
Casual blood glucose level, HbA1c		Casual blood glucose level, HbA1c