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.
Diagnosed with Type 2 diabetes according to the 1999 WHO criteria
Aged ≥18 years
UACR ≥30 mg/g and eGFR ≥30 ml/min/1.73 m² sustained for over 3 months
Stable ARB/ACEI treatment for ≥4 weeks prior to enrollment
Chronic kidney disease diagnosed before Type 2 diabetes
Serum potassium >4.8 mmol/L
Ineffective blood pressure control at screening (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg, average of three measurements in the supine position)
HbA1c >9%
This study aims to evaluate the effects of finerenone on renal function and diabetic complications in patients with Type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). The study population consists of adult patients diagnosed with T2DM and CKD who meet specific inclusion and exclusion criteria.
Other
Prospective
Finerenone
DrugTreatment will continue for 48 weeks.
Change in Urine Albumin-to-Creatinine Ratio (UACR)
The primary outcome measure is the change in Urine Albumin-to-Creatinine Ratio (UACR) from baseline to the end of the 48-week treatment period. UACR is a key indicator of renal function and will be assessed to evaluate the efficacy of finerenone in reducing proteinuria in patients with Type 2 diabetes and chronic kidney disease.
Change in eGFR
The change in estimated Glomerular Filtration Rate (eGFR) from baseline to the end of the 48-week treatment period. eGFR is a key marker of renal function and will be used to assess the impact of finerenone on kidney function in patients with Type 2 diabetes and chronic kidney disease.
Change in 24-Hour Urine Protein Quantification
The change in 24-hour urine protein quantification from baseline to the end of the 48-week treatment period. This measure will provide additional insight into the effect of finerenone on proteinuria in patients with chronic kidney disease.
Change in Blood Uric Acid Levels
The change in serum uric acid levels from baseline to the end of the 48-week treatment period. Elevated uric acid levels are associated with renal dysfunction, and this measure will help assess the broader metabolic effects of finerenone.
Change in Pulse Wave Velocity (PWV)
The change in pulse wave velocity (PWV) from baseline to the end of the 48-week treatment period. PWV is a measure of arterial stiffness and will be used to assess the impact of finerenone on cardiovascular health.
Click on the lead sponsor to view all of their trials.
