Actively Recruiting
Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease
Led by Second Affiliated Hospital of Soochow University · Updated on 2025-04-04
300
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Type 2 diabetes according to the 1999 WHO criteria
- Aged 18 years or older
- Urine albumin-to-creatinine ratio (UACR) 30 mg/g or higher and eGFR 30 ml/min/1.73 m² or higher sustained for over 3 months
- Stable treatment with ARB or ACEI medications for at least 4 weeks prior to enrollment
- Willing to sign informed consent and follow the study protocol
You will not qualify if you...
- Chronic kidney disease diagnosed before Type 2 diabetes
- Serum potassium level higher than 4.8 mmol/L
- Poor blood pressure control at screening with systolic blood pressure 160 mmHg or higher and/or diastolic blood pressure 100 mmHg or higher
- Hemoglobin A1c (HbA1c) greater than 9%
- Acute urinary tract infection or other conditions affecting urine tests
- Primary or secondary adrenal insufficiency
- Use of mineralocorticoid receptor antagonists
- Use of medications affecting urine protein and eGFR within 4 weeks (except kininogenase)
- Use of strong CYP3A4 inhibitors such as itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone, carbamazepine
- Elevated liver enzymes ALT or AST more than 2.5 times the upper limit of normal or total bilirubin more than 2 times the upper limit of normal
- Use of systemic glucocorticoids for more than 7 days within 12 weeks prior to screening or need for systemic immunosuppressive treatment within 14 days
- Any organ system cancer within the past 5 years
- Known pregnancy, breastfeeding, recent plans for conception, or not using adequate contraception
- Participation in other interventional clinical trials within 3 months prior to screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Actively Recruiting
Research Team
X
Xie Ying, Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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