Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059852) titled 'A clinical study comparing the renal effects of dotinurad and febuxostat in patients with chronic kidney disease and hyperuricemia' on Nov. 30.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Toho University

Condition: Condition - hyperuricemia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to compare and verify the renoprotective effects (assessed by eGFR slope) of dotinurad (a SURI) versus febuxostat (an XOI) in patients with stage 3 or 4 CKD and asymptomatic hyperuricemia. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 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 according to the package insert and the attending physician's clinical judgment, targeting a serum uric acid level of 15 and 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). Key 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. Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 30 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2028 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068441

Disclaimer: Curated by HT Syndication.