Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)

Inclusion Criteria:

• Men or women ≥18 years of age
• Type 2 diabetes mellitus (T2D) as defined by the American Diabetes Association

• Diagnosis of chronic kidney disease (CKD) with at least one of the following criteria at run-in and screening visits:

  • persistent high albuminuria (UACR ≥30 to <300 mg/g in 2 out of 3 first morning void samples) and estimated glomerular filtration rate (eGFR) ≥25 but <60 mL/min/1.73 m² (CKD EPI) and presence of diabetic retinopathy or
  • persistent very high albuminuria (UACR ≥300 mg/g in 2 out of 3 first morning void samples) and eGFR ≥25 to <75 mL/min/1.73 m² (CKD-EPI)

• Prior treatment with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) as follows:

  • For at least 4 weeks prior to the run-in visit, subjects should be treated with either an ACEI or ARB, or both
  • Starting with the run-in visit, subjects should be treated with only an ACEI or ARB
  • For at least 4 weeks prior to the screening visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an ACEI or an ARB (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment
• Serum potassium ≤4.8 mmol/L at both the run-in and the screening visit

Exclusion Criteria:

• Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
• Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg, sitting diastolic blood pressure (DBP) ≥110 mmHg at run-in visit, or mean sitting SBP ≥160 mmHg, sitting DBP ≥100 mmHg at screening)
• Glycated hemoglobin (HbA1c) >12%
• Mean SBP < 90 mmHg at the run-in visit or at the screening visit
• Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association [NYHA] class II - IV) at run-in visit (class 1A recommendation for mineralcorticoid receptor antagonists [MRAs])
• Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the screening visit
• Dialysis for acute renal failure within 12 weeks of run-in visit
• Renal allograft in place or scheduled within next 12 months from the run-in visit