Clinical Trial

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

Study acronym: KSD-01
Recruiting
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Record status
This record was last updated April 4, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-17.
Trial Details
NCT Number NCT06838416
Lead Sponsor Second Affiliated Hospital of Soochow University
Conditions Type 2 Diabetes Mellitus, Chronic Kidney Disease, Renal Function
Enrollment 300 participants
Start Date 2023-11-17
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-04