Finerenone for Regression of Albuminuria in Type 2 Diabetes With Chronic Kidney Disease

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• 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.

Egyéb

• 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.

• 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.