This is a single-center prospective observational clinical study conducted at the First Affiliated Hospital of Chongqing Medical University. A total of 425 patients aged 18-75 years with type 2 diabetes mellitus-related chronic kidney disease will be enrolled from February 2026 to January 2029. All participants will receive standard finerenone treatment in accordance with clinical guidelines with a 4-month follow-up period. Blood and urine samples will be collected at screening, baseline, 1 month, 2 months and 4 months after treatment initiation for routine biochemistry, aldosterone/renin testing, captopril suppression test and multi-omics analysis.
Participants will be categorized into benefit group, partial benefit group and non-benefit group based on the reduction rate of urine albumin-to-creatinine ratio (UACR) at Month 4. We will combine demographic data, laboratory indicators and multi-omics profiles to identify key biomarkers predicting finerenone response, and construct a predictive model to realize precise individualized therapy for diabetic kidney disease.
All study-related laboratory tests are free of charge for subjects. A priority consultation channel is available during follow-up, and free professional consultation on diabetic nephropathy will be provided. Serum potassium and renal function will be closely monitored to manage safety risks such as hyperkalemia. All personal data and biological samples are anonymized and stored in encrypted systems with strict confidentiality protection. Subjects may withdraw from the study voluntarily at any time without interference to their routine clinical care.
Inclusion Criteria:
Exclusion Criteria:
All enrolled participants with type 2 diabetes mellitus-related chronic kidney disease receive guideline-standard oral finerenone therapy for a 4-month observation period. The finerenone dose is adjusted according to each subject's baseline eGFR and serum potassium level following the official drug instructions. Concomitant hypoglycemic, antihypertensive and lipid-lowering medications remain stable during the whole study period as required by inclusion criteria. Serial blood and urine biospecimens are collected at multiple follow-up time points for routine biochemical tests, captopril suppression test and multi-omics detection. After 4 months of treatment, subjects will be divided into three analytic subgroups based on UACR reduction rate to explore predictive biomarkers of finerenone efficacy.
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