Tokyo, Jan. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060295) titled 'Evaluation of the efficacy of switching from a xanthine oxidase inhibitor (febuxostat) to a selective urate reabsorption inhibitor (dotinurad) in patients with hyperuricemia and chronic kidney disease (CKD)' on Jan. 8.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - NHO Higashihiroshima Medical Center

Condition: Condition - Hyperuricemia with chronic kidney disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Xanthine oxidase inhibitors are widely used for patients with hyperuricemia and chronic kidney disease (CKD); however, their renoprotective effects remain controversial. Meanwhile, there is currently a paucity of reports regarding the effects of uricosuric agents on renal function in this patient population. The purpose of this study is to investigate the impact on renal function of switching from a xanthine oxidase inhibitor to a uricosuric agent in patients with hyperuricemia and CKD. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Patients were switched from the xanthine oxidase inhibitor febuxostat to the selective urate reabsorption inhibitor dotinurad, with the dosage adjusted according to the following conversion protocol: Febuxostat 10 mg/day to dotinurad 0.5 mg/day Febuxostat 20 mg/day to dotinurad 1 mg/day Febuxostat 40 mg/day to dotinurad 2 mg/day

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Patients aged 20 years or older with hyperuricemia and stage G2-G4 chronic kidney disease (CKD) who are not undergoing dialysis.

(2) Patients currently receiving the xanthine oxidase inhibitor febuxostat. Key exclusion criteria - (1) Presence of active gouty arthritis.

(2) Any other conditions that the attending physician considers unsuitable for study participation Target Size - 60

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 03 Month 10 Day Date of IRB - 2025 Year 03 Month 07 Day Anticipated trial start date - 2025 Year 04 Month 01 Day Last follow-up date - 2025 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068976

Disclaimer: Curated by HT Syndication.