Evaluation of tubular protective effects of selective urate reabsorption inhibitors

Effects of Dotinurad, a Selective Urate Reabsorption Inhibitor, on Tubular Injury Markers in Patients with CKD - SURI-CKD trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051250135

Enrollment

Registered

2025-10-31

Start date

2025-12-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease chronic kidney disease, hyperuricemia

Interventions

1. Intervention Group (Dotinurad Group) The initial dose of dotinurad will be 0.5 mg. The target serum urate level will be set at =10.0 mg/dL even at the maximum dose, febuxostat will be added. Dose a

however, changes may be allowed if deemed clinically necessary by the attending physician. 2. Control Group (Febuxostat Group) The initial dose of febuxostat will be 10 mg. The target serum urate lev

however, changes may be allowed if deemed clinically necessary by the attending physician.

Selective Urate Reabsorption Inhibitor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 20 years or older at the time of consent 2. Patients with an estimated glomerular filtration rate (eGFR) of >=15 mL/min/1.73 m^2 and =8 mg/dL or currently receiving treatment with xanthine oxidase inhibitors 4. Patients currently taking renin-angiotensin system (RAS) inhibitors or angiotensin receptor-neprilysin inhibitors (ARNIs) 5. Patients who have provided written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. Patients already receiving urate reabsorption inhibitors (dotinurad, benzbromarone, or probenecid) 2. Patients who have undergone kidney transplantation 3. Patients with a history of gout 4. Patients currently taking mercaptopurine hydrate or azathioprine 5. Patients with aspartate aminotransferase (AST) levels >=100 IU/L or alanine aminotransferase (ALT) levels >=100 IU/L 6. Patients with a history of urinary tract stones 7. Patients with an allergy to febuxostat or dotinurad 8. Patients who are planning pregnancy, currently pregnant, or breastfeeding 9. Patients deemed inappropriate for study participation by the attending physician for any other reason

Design outcomes

Primary

Measure	Time frame
Change in urinary KIM-1 levels from baseline to week 24	—

Secondary

Measure	Time frame
Changes in the following laboratory parameters from baseline to week 24: 1. Urinary beta2-microglobulin 2. Urinary alpha1-microglobulin 3. Urinary neutrophil gelatinase-associated lipocalin (NGAL) 4. Urinary liver-type fatty acid-binding protein (L-FABP) 5. Urinary albumin 6. Urine protein-to-creatinine ratio (UPCR) 7. estimated glomerular filtration rate (eGFR) 8. Serum urate level 9. Urinary urate-to-creatinine ratio 10. AST, ALT 11. The number of adverse events	—

Measure

Time frame

Changes in the following laboratory parameters from baseline to week 24: 1. Urinary beta2-microglobulin 2. Urinary alpha1-microglobulin 3. Urinary neutrophil gelatinase-associated lipocalin (NGAL) 4. Urinary liver-type fatty acid-binding protein (L-FABP) 5. Urinary albumin 6. Urine protein-to-creatinine ratio (UPCR) 7. estimated glomerular filtration rate (eGFR) 8. Serum urate level 9. Urinary urate-to-creatinine ratio 10. AST, ALT 11. The number of adverse events

—

Contacts

Public ContactYusuke Sakaguchi

The University of Osaka Hospital

sakaguchi@kid.med.osaka-u.ac.jp+81-668793857

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026