Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059065) titled 'Study on renal protective effect of serum urate lowering therapy' on Sept. 12.

Study Type: Interventional

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

Primary Sponsor: Institute - Tokushukai Medical Corporation Shonan Kamakura General Hospital (Clinical Research Center)

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

Objective: Narrative objectives1 - To follow and compare the rate of decline in eGFR at the start of treatment and every 24 weeks for 3 years in more tightly controlled serum uric acid levels Basic objectives2 - Others

Intervention: Interventions/Control_1 - For patients with serum uric acid levels>6.0mg/dl,dotinurad 0.5mg/day will be added,or the dotinurad dosage will be adjusted so that serum uric acid levels are 2-6mg/dl and serum uric acid fluctuations are within 0.5mg/dl with follow-up every 4(+/-2) weeks, and continued for up to 2 months. The choice of additional administration group or switch group will be made at the discretion of the attending physician based on the type of uric acid lowering drug,the patient's wishes,personality,compliance,etc.For uric acid levels 6.0mg/dl),dotinurad 0.5mg/day will be started after obtaining consent. Increase dotinurad to keep serum uric acid levels within 2-6mg at follow-up every 4(+/-2) weeks Interventions/Control_2 - (ii) Dotinurad addition group taking other uric acid-lowering drugs: Start dotinurad 0.5 mg/day as above after obtaining consent *Switching of uric acid excretion-promoting drugs is recommended to prevent renal urinary tract stones.

Eligibility: Age-lower limit - 18 years-old 6.0 mg/dl) 2) Patients without renal urinary tract stones on computed tomography (CT) 3) Patients aged 20 years or older (regardless of gender) at the time of consent 4) Patients who have been fully informed about their participation in this study and have given their free written consent to participate in the study after having been fully informed of the study 5) Patients who are attending an outpatient clinic at the time of consent Key exclusion criteria - 1) Patients with hypouricemia (<2.0 mg/dl) 2) Patients with a history of urinary tract stones or the presence of renal UTI stones evident on imaging 3) Patients who have taken Dotinurado. within 26 weeks prior to obtaining consent 4) Women who are pregnant or may become pregnant 5) Women who are breastfeeding 6) Patients who received other study drugs or investigational drugs within 3 months before starting study drug administration 7) Patients with a history of hypersensitivity to any component of the study drug 8) Other patients deemed unsuitable as study subjects by the principal investigator Target Size - 150

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 08 Month 20 Day Date of IRB - 2025 Year 09 Month 03 Day Anticipated trial start date - 2025 Year 09 Month 12 Day Last follow-up date - 2029 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066663

Disclaimer: Curated by HT Syndication.