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
Second Affiliated Hospital of Soochow University
300 participants
Nov 17, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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
- Willing to sign a written informed consent and comply with the study protocol
Exclusion Criteria14
- 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%
- Acute urinary tract infection or conditions affecting urine tests
- Primary or secondary adrenal insufficiency
- Use of mineralocorticoid receptor antagonists
- Use of medications with clear effects on urine protein and eGFR within 4 weeks (except kininogenase)
- Use of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone, carbamazepine)
- ALT or AST \>2.5 × ULN, total bilirubin (TBIL) \>2 × ULN
- Use of systemic glucocorticoids for more than 7 days within 12 weeks prior to screening, or use of systemic glucocorticoids (intravenous/oral or intra - articular) or need for systemic immunosuppressive treatment within the past 14 days
- Any organ system cancer within the past 5 years, whether treated or untreated
- Known pregnancy (positive pregnancy test), breastfeeding, recent plans for conception, or not using adequate contraception
- Participation in other interventional clinical trials within 3 months prior to screening
Interventions
Treatment will continue for 48 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06838416