An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People with Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Study drug and medical condition

• Medicinal product name:
  KERENDIA
• Study drug International non-proprietary name (INN) or common name:
  FINERENONE
• Anatomical Therapeutic Chemical (ATC) code:
  (C03DA05) finerenone

  finerenone
• Medical condition to be studied:
  Chronic kidney disease

  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Patients with CKD and T2D initiating finerenone and patients with CKD and T2D not using finerenone. This study will be conducted using existing healthcare data from the US. Considered data sources include the HealthVerity® Chronic Kidney Disease Masterset.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  150000

Study design details

• Main study objective:
  To assess the effectiveness of finerenone by estimating the risk of a composite cardiovascular outcome (i.e., first occurrence of fatal or nonfatal acute myocardial infarction or hospitalisation for heart failure) in patients with CKD and T2D initiating finerenone compared with that in patients with CKD and T2D not using finerenone.
• Outcomes:
  Primary Outcomes:; Time to the first occurrence of composite cardiovascular outcome.; ; Secodary Outcomes:; Time to the first occurrence of an inpatient hospital diagnosis of fatal or nonfatal acute myocardial infarction.; Time to the first occurrence of an inpatient hospitalisation with a primary diagnosis of heart failure.; Time to the first occurrence of an inpatient hospital or emergency department diagnosis of heart failure for participants without a history of heart failure.; Time to occurrence of specific Urine Albumin-Creatine Ratio (UACR) decline thresholds.; Time to the first occurrence of a hospitalisation or emergency department visit with a diagnosis code for hyperkalaemia.