Finerenone and kidney function in adults with type 2 diabetes
Studies finerenone added to usual care in adults with diabetes and kidney disease.
Plain-language title generated from the registry record
Registry title: Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease
Key facts
- Where
- Suzhou, ChinaSee the site
Where in China
- The Second Affiliated Hospital of Suzhou UniversitySuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital of Soochow University
- Trial code
- NCT06838416
- Record updated
- 4 April 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Use of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone, carbamazepine); 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; Participation in other interventional clinical trials within 3 months prior to screening; Chronic kidney disease diagnosed before Type 2 diabetes; Acute urinary tract infection or conditions affecting urine tests; Primary or secondary adrenal insufficiency; Any organ system cancer within the past 5 years, whether treated or untreated; Serum potassium >4.8 mmol/L; HbA1c >9%; Use of medications with clear effects on urine protein and eGFR within 4 weeks (except kininogenase); ALT or AST >2.5 × ULN, total bilirubin (TBIL) >2 × ULN; Ineffective blood pressure control at screening (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg, average of three measurements in the supine position); Use of mineralocorticoid receptor antagonists; Known pregnancy (positive pregnancy test), breastfeeding, recent plans for conception, or not using adequate contraception.