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
Study ID
NCT07717697
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Finerenone — DRUG
    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.

Study Details

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 Dates

First listed
Jul 21, 2026
Start date
Jul 30, 2026
Status verified
Jul 2026
Primary completion
Jan 30, 2029
Completion
Jan 30, 2029

Study Design

Enrollment
425 participants (estimated)

Arms

  • Arm: Finerenone Treatment Cohort
    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.

Primary Outcome Measure

Key biomarkers associated with therapeutic response to finerenone [ Time Frame: 4 months after finerenone initiation ]

Find similar trials

Nationwide
Type 2 diabetes trialsEndocrinology trialsMetabolic health trialsWeight loss trials

Related Studies