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

NCT07717697 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: 2026-0256-01
• Study Type: observational
• Target: 425
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Diabetic Kidney Disease

Keywords

Finerenone; Type 2 diabetes mellitus; Diabetic kidney disease; Predictive model; Prospective observational study

Outcome Measures

Primary Outcomes (1)

• Key biomarkers associated with therapeutic response to finerenone

  Identify core multi-omics, biochemical and clinical biomarkers that predict whether patients with type 2 diabetes-related chronic kidney disease can achieve renal benefit from finerenone treatment.

  4 months after finerenone initiation

Secondary Outcomes (4)

• Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline to Month 4

  Baseline, Month 4

• Serial change in estimated glomerular filtration rate (eGFR)

  Baseline, Month 1, Month 2, Month 4

• Serial change in serum potassium

  Baseline, Month 1, Month 2, Month 4

• Changes in plasma aldosterone and renin at Month 4

  Baseline, Month 4

Study Arms (1)

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.

Drug: Finerenone

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.

Finerenone Treatment Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational cohort study enrolling patients with type 2 diabetes mellitus (T2DM) complicated with chronic kidney disease (CKD) receiving finerenone therapy. Subjects will be recruited from the Chongqing Diabetes Registry (CDR), endocrine outpatient and inpatient departments of the First Affiliated Hospital of Chongqing Medical University, with a recruitment window from February 2026 to January 2029. A total of 425 eligible participants are planned to be enrolled. A target sample size of 425 participants is determined using the R pmsampsize package for predictive model development. Key input parameters: C-statistic of 0.80, 10 candidate predictive variables, expected finerenone responder proportion of 53.2% derived from FIDELIO-DKD and FIGARO-DKD trials. The minimum required sample size to satisfy model stability and calibration criteria is 383 participants. A 10% attrition rate is accounted for, leading to the final enrolment target of 425 patients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, blood clot, random urine samples collected at screening, baseline, month 1, month 2 and month 4 visits. All biospecimens are cryopreserved at -80°C for laboratory tests and multi-omics analysis including DNA extraction, and will be destroyed after completion of all study analyses.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies

Interventions

finerenone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): January 30, 2029
• Study Completion (Estimated): January 30, 2029
• Last Updated: July 21, 2026

Record last verified: 2026-07