RecruitingNCT06838416

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

Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease: A Prospective, Single-Arm, Multicenter Clinical Study

Sponsor

Second Affiliated Hospital of Soochow University

Enrollment

300 participants

Start Date

Nov 17, 2023

Study Type

OBSERVATIONAL

Conditions

Chronic Kidney Disease Type 2 Diabetes Mellitus Renal Function

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether finerenone — a newer type of kidney-protecting medication that blocks mineralocorticoid receptors — can slow the progression of kidney disease in people with type 2 diabetes who also have significant protein in their urine, which signals kidney damage. **You may be eligible if...** - You are 18 or older with a confirmed type 2 diabetes diagnosis - You have kidney disease with protein leakage (UACR ≥30 mg/g) and kidney filtration rate of at least 30 ml/min - Your kidney disease has been present for at least 3 months - You have been on a stable dose of an ACE inhibitor or ARB blood pressure medication for at least 4 weeks **You may NOT be eligible if...** - Your kidney disease started before your diabetes diagnosis - Your blood potassium is too high (above 4.8 mmol/L) - Your blood pressure is very poorly controlled - Your HbA1c is above 9% - You are already taking a mineralocorticoid receptor blocker - You have adrenal gland problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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