Tokyo, Oct. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063230) titled 'Effectiveness and safety of continuous low-dose (10 mg/day) finerenone administration in patients with type 2 diabetes and chronic kidney disease' on Oct. 9.

Study Type: Observational

Primary Sponsor: Institute - Edogawa Hospital

Condition: Condition - Patients with type 2 diabetes and chronic kidney disease. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the clinical effectiveness (changes in urinary albumin-to-creatinine ratio and estimated glomerular filtration rate) and safety (changes in serum potassium levels) of continuous low-dose (10 mg/day) finerenone therapy over 6 months in patients with type 2 diabetes and chronic kidney disease in a real-world clinical setting. Furthermore, this study aims to explore baseline objective indicators for safe treatment continuation by identifying factors associated with early serum potassium elevation. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with type 2 diabetes and chronic kidney disease. 2. Patients who initiated finerenone at 10 mg/day between August 2023 and December 2025 at our outpatient clinic. 3. Patients who continuously received finerenone at 10 mg/day for 6 months based on the clinical judgment of their attending physicians. Key exclusion criteria - 1. Patients whose finerenone dose was increased to 20 mg/day within 6 months. 2. Patients with an observation period of less than 6 months (e.g., due to death, transfer, or lost to follow-up). 3. Patients who discontinued finerenone due to adverse events or other clinical reasons within 6 months. Target Size - 60

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2026 Year 08 Month 25 Day Date of IRB - 2026 Year 10 Month 02 Day Anticipated trial start date - 2026 Year 10 Month 09 Day Last follow-up date - 2026 Year 10 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072372

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