hyperuricemia
Conditions
Interventions
Dotinurad group:Oral administration of dotinurad, a selective urate reabsorption inhibitor (SURI). The duration of administration is 24 months (2 years). Dosage and administration are adjusted accordi
s clinical judgment, targeting a serum uric acid level of <
6.0 mg/dL. In principle, the drug is used within the standard dosage range (starting dose 0.5 mg/day, maintenance dose 1-4 mg/day).
Febuxostat group:Oral administration of febuxostat, a xanthine oxida
6.0 mg/dL. In principle, the drug is used within the standard dosage range (starting dose 10 mg/day, maintenance dose 10-60 mg/day).
Sponsors
Toho University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older at the time of informed consent. Patients with Chronic Kidney Disease (CKD) stage 3 or 4 (eGFR >15 and <60 mL/min/1.73m2 within 12 weeks prior to registration). Patients with asymptomatic hyperuricemia (serum uric acid level >7.0 mg/dL recorded at least once within 12 weeks prior to registration). Patients who have received a stable dose of Angiotensin-Converting Enzyme (ACE) inhibitor or Angiotensin II Receptor Blocker (ARB) for at least 1 month prior to registration, if indicated and tolerated. (Patients for whom these drugs are medically contraindicated or not indicated are eligible without their use).
Exclusion criteria
Exclusion criteria: Patients with difficulty in providing informed consent or adhering to medication (e.g., severe dementia visiting alone, significant poor compliance). Patients diagnosed with symptomatic gout, or those who have taken urate-lowering drugs within 12 weeks prior to study initiation. Patients who have initiated or changed the dose of RAS inhibitors or SGLT2 inhibitors within 4 weeks prior to registration. Patients undergoing treatment for malignancy (excluding carcinoma in situ). Patients undergoing dialysis, those who have received a kidney transplant, or those scheduled for kidney transplantation within 6 months. Patients participating in other interventional studies or clinical trials. Patients who are pregnant, breastfeeding, or possibly pregnant. Patients with a history of hypersensitivity to febuxostat or dotinurad. Patients receiving mercaptopurine hydrate or azathioprine (contraindicated with febuxostat). Patients undergoing treatment for urinary calculi (contraindication for urate excretion promoters). Patients with active liver disease defined as AST or ALT >3 times the upper limit of normal. Patients with polycystic kidney disease. Patients who developed acute kidney injury (AKI) within 3 months prior to consent and have not recovered. Patients with urinary protein-to-creatinine ratio (UPCR) >5 g/gCr or urinary albumin-to-creatinine ratio (UACR) >3000 mg/gCr in the latest spot urine test prior to consent. Other patients judged inappropriate by the investigator from the viewpoint of study conduct or ethics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual eGFR slope over the 24-month (2-year) period after treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of clinical events: All-cause mortality, renal events (defined as a <30% decline in eGFR from baseline or progression to End-Stage Kidney Disease [ESKD]), cardiovascular events, and hospitalization events. Achievement rate of target serum uric acid levels (<6.0 mg/dL). Changes in urinary tubular injury markers from baseline: Short-term changes at 1 month and long-term changes over 2 years. Changes in safety parameters: Complete blood count, liver function (AST, ALT), kidney function (BUN, Cr, eGFR), electrolytes (Na, K, Cl), and inflammatory markers (CRP).Changes in comorbidity management indices: HbA1c or glycated albumin in patients with diabetes; TC, TG, LDL-C, and HDL-C in patients with dyslipidemia or cardiovascular complications. | — |
Countries
Japan
Contacts
Public ContactHikaru Uematsu
Toho University Ohashi Medical Center Department of Nephrology
Outcome results
None listed