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NCT07717697

Finerenone for the Treatment of Type 2 Diabetes-Related Kidney Disease: Efficacy Observation and Related Factor Analysis

Sponsor: First Affiliated Hospital of Chongqing Medical University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

425

Start Date

2026-07-30

Completion Date

2029-01-30

Last Updated

2026-07-21

Healthy Volunteers

Conditions

Type 2 Diabetes Mellitus Diabetic Kidney Disease

Interventions

DRUG

Finerenone

Oral finerenone administered once daily for 4 months. Dosage is individualized based on baseline estimated glomerular filtration rate (eGFR) and serum potassium per drug labeling. Subjects maintain stable background hypoglycemic, antihypertensive and lipid-lowering therapies throughout the observational period. No additional study-specific drugs or experimental procedures are applied; only routine clinical finerenone treatment is observed with serial blood and urine sample collection for multi-omics and biomarker analysis.

Inclusion Criteria: * Aged 18-75 years, male or female, with full capacity for independent conduct. * Confirmed type 2 diabetes-associated chronic kidney disease (CKD): Random urine albumin-to-creatinine ratio (UACR) of 100-5000 ug/mg Cr on two non-consecutive days; estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI formula \>25 mL/min/1.73m²; Finerenone treatment is indicated per clinical guidelines. * All concomitant medications have remained stable for 3 months prior to screening, with no planned treatment adjustments throughout the trial. Stable medication is defined as dose adjustments not exceeding ±25% of the screening baseline dose. * If the glycemic regimen includes sodium-glucose cotransporter 2 inhibitors (SGLT-2i): The daily SGLT-2i dose remains constant for 3 months before screening, and no daily dose changes are planned during the entire trial. If the glycemic regimen excludes SGLT-2i: No SGLT-2i exposure within 4 weeks prior to screening, and no SGLT-2i initiation is planned throughout the trial. * If the glycemic regimen includes glucagon-like peptide-1 receptor agonists (GLP-1RA): The daily GLP-1RA dose remains constant for 3 months before screening, and no daily dose changes are planned during the entire trial. If the glycemic regimen excludes GLP-1RA: No GLP-1RA exposure within 4 weeks prior to screening, and no GLP-1RA initiation is planned throughout the trial. * Fully understands the entire trial procedure, voluntarily participates in the study and signs the informed consent form. Exclusion Criteria: * Diagnosed or suspected type 1 diabetes, special type diabetes or secondary diabetes. * Poor glycemic control with glycated hemoglobin (HbA1c) \>9.0%. * Average seated office blood pressure measured over 3 visits with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg. * Serum potassium \>5.0 mmol/L without potassium supplementation. * Diagnosed or suspected chronic kidney disease unrelated to diabetic nephropathy. * Complicated with liver cirrhosis or moderate-to-severe liver impairment. * Patients with secondary aldosteronism and primary aldosteronism who have surgery plans within six months. * Confirmed Addison's disease. * Complicated with uncontrolled autoimmune diseases. * Complicated with active malignant tumors. * Presence or suspicion of depression, bipolar disorder, suicidal tendency, schizophrenia or other severe mental illnesses; or lack of mental capacity or language barrier, unable to fully understand the trial protocol or unwilling to cooperate with study site staff. * Complicated with other uncontrolled chronic diseases. * Use of serum potassium-elevating agents (e.g., amiloride, triamterene) or other mineralocorticoid receptor antagonists (MRAs, e.g., spironolactone, eplerenone) within 4 weeks prior to screening. * Use of strong CYP3A4 inhibitors (itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone) or CYP3A4 inducers (carbamazepine, phenytoin, erythromycin, fluvoxamine) within 2 weeks prior to screening. * Pregnant or breastfeeding women.