Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease

Sponsor
Second Affiliated Hospital of Soochow University
Study ID
NCT06838416
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Finerenone — DRUG
    Treatment will continue for 48 weeks.

Study Details

Research Objectives To evaluate the impact of finerenone on renal function, diabetic complications, and safety in patients with Type 2 diabetes and chronic kidney disease. Study Design Type: Prospective, single-arm, multicenter clinical trial. Sample Size: 300 patients. Intervention: Finerenone added to existing treatment regimen (10-20 mg once daily, dose adjusted based on eGFR), for 48 weeks. Data Collection Time Points: Baseline, 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks. Primary Endpoint: Change in urine albumin-to-creatinine ratio (UACR). Secondary Endpoints: Changes in eGFR, 24-hour urine protein, serum uric acid, retinopathy markers, pulse wave velocity (PWV), ankle-brachial index (ABI), etc. Safety Endpoints: Changes in serum potassium, sodium, and blood pressure.

Key Dates

Start date
Nov 17, 2023
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Finerenone Treatment Group
    All enrolled participants will receive finerenone as an add-on to their existing stable treatment regimen. The dose of finerenone will be adjusted based on eGFR levels at enrollment (10 mg once daily if eGFR \< 60 mL/min/1.73 m²; 20 mg once daily if eGFR ≥ 60 mL/min/1.73 m²).

Primary Outcome Measure

Change in Urine Albumin-to-Creatinine Ratio (UACR) [ Time Frame: Baseline to Week 48 ]

Central Contacts

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