Finerenone Tested for Albuminuria in Type 2 Diabetes With Kidney Disease

Trial details

Who runs it

First Affiliated Hospital of Zhejiang University

Trial code

NCT07667517

Record updated

25 June 2026

Original description

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, for the early regression of albuminuria in adults with type 2 diabetes mellitus and chronic kidney disease (eGFR >= 30 mL/min/1.73 m\^2 and UACR 30-2000 mg/g) who are already receiving a maximum tolerated dose of an ACE inhibitor or ARB. A total of 148 participants are randomized 1:1, stratified by baseline UACR (<300 vs >=300 mg/g), to oral finerenone (10 or 20 mg once daily, titrated by serum potassium and eGFR) or matching placebo, on top of standard background therapy, for 180 days, followed by a 30-day off-treatment follow-up. Albuminuria regression is defined as both an improvement in Kidney Disease: Improving Global Outcomes albuminuria category, from A3 to A2 or A1, or from A2 to A1, and a more than 30% reduction in urinary albumin-to-creatinine ratio from baseline. The outcome will be reported as the percentage of participants meeting this definition at Day 180.Read full original descriptionShow less

Efficacy and Safety of Finerenone for the Early Regression of Albuminuria in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, for the early regression of albuminuria in adults with type 2 diabetes mellitus and chronic kidney disease (eGFR >= 30 mL/min/1.73 m\^2 and UACR 30-2000 mg/g) who are already receiving a maximum tolerated dose of an ACE inhibitor or ARB. A total of 148 participants are randomized 1:1, stratified by baseline UACR (<300 vs >=300 mg/g), to oral finerenone (10 or 20 mg once daily, titrated by serum potassium and eGFR) or matching placebo, on top of standard background therapy, for 180 days, followed by a 30-day off-treatment follow-up. Albuminuria regression is defined as both an improvement in Kidney Disease: Improving Global Outcomes albuminuria category, from A3 to A2 or A1, or from A2 to A1, and a more than 30% reduction in urinary albumin-to-creatinine ratio from baseline. The outcome will be reported as the percentage of participants meeting this definition at Day 180.

Inclusion: 1. Age >= 18 years at the time of signing informed consent, male or female; 2. Type 2 diabetes mellitus; 3. Chronic kidney disease meeting BOTH of the following: eGFR (CKD-EPI) >= 30 mL/min/1.73 m\^2, and UACR 30-2000 mg/g (mean of 3 measurements); 4. Serum potassium <= 5.0 mmol/L; 5. On a maximum tolerated dose of an ACE inhibitor or ARB for at least 90 days; 6. Treatment with an SGLT-2 inhibitor, GLP-1 receptor agonist, or other agents affecting UACR is permitted, but the type and dose must be stable for at least 30 days before screening.

Exclusion: 3. On renal replacement therapy; 4. Acute kidney injury within 180 days before the screening visit; 9. Treatment with finerenone within 60 days before screening; 10. Stroke, transient ischemic attack, acute coronary syndrome (myocardial infarction, CABG, PCI), or hospitalization for worsening heart failure within 90 days before the screening visit; 13. Gastrointestinal surgery that may affect drug absorption; 14. Any other history, condition, therapy, or uncontrolled concomitant disease that makes the participant unsuitable for the study or unlikely to complete it (e.g., active malignancy or other disease with life expectancy < 12 months); 15. Treatment with a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin, nefazodone), a strong CYP3A4 inducer (e.g., carbamazepine, phenytoin, phenobarbital, St. John's wort), or a moderate CYP3A4 inducer (e.g., efavirenz) that cannot be discontinued for at least 7 days before randomization; 18. Immunosuppressive therapy, or glucocorticoid use by any route other than topical or inhaled, within the past 180 days; 19. Participation in another interventional clinical study or use of any investigational product within 90 days before randomization; 1. Type 1 diabetes, other specific types of diabetes, or gestational diabetes; 5. Hepatic impairment (Child-Pugh class C); 8. Known hypersensitivity to the study drug (active substance or excipients); 11. NYHA class II-IV heart failure; 12. Addison's disease; 17. Biopsy-confirmed non-diabetic kidney disease (e.g., IgA nephropathy); 20. History of alcohol or drug abuse; 22. Any other condition deemed by the investigator to make the participant unsuitable for the study; 2. HbA1c >= 8.0%; 16. Treatment with another mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone, esaxerenone) or a potassium-sparing diuretic (e.g., amiloride, triamterene) that cannot be discontinued for at least 60 days before the screening visit; 6. Blood pressure > 160/100 mmHg, or systolic blood pressure < 90 mmHg, at the screening visit; 7. Bilateral renal artery stenosis; 21. Women of childbearing potential who are pregnant, breastfeeding, intend to become pregnant, or are not using adequate contraception during the study.

ClinicalTrials.gov NCT07667517