Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease
NCT06838416 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2025-04-04
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.
Conditions
- Type 2 Diabetes Mellitus
- Chronic Kidney Disease
- Renal Function
Interventions
- DRUG
-
Treatment will continue for 48 weeks.
Sponsors & Collaborators
-
Second Affiliated Hospital of Soochow University
lead OTHER
Principal Investigators
-
Xie Ying, Ph.D. · Second Affiliated Hospital of Suzhou University
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-17
- Primary Completion
- 2025-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- China
Study Locations
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