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

Launched by SECOND AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Feb 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called finerenone on kidney health in patients who have both Type 2 diabetes and chronic kidney disease. The goal is to see how well finerenone can improve kidney function and manage diabetes-related complications over a period of 48 weeks. The trial will include around 300 participants who will take finerenone daily while continuing their usual diabetes treatments. Researchers will measure changes in kidney function and safety through urine and blood tests at various points during the study.

To be eligible for the trial, participants need to be at least 18 years old, diagnosed with Type 2 diabetes, and have specific kidney function levels. They should also have been on stable blood pressure medication for at least four weeks before joining. However, individuals with certain health issues or conditions that could affect the study, such as uncontrolled high blood pressure or significant liver problems, will not be included. Participants can expect regular check-ups and tests to monitor their health and the effects of the medication throughout the study.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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