FINErenone druG Utilization Study and assessment of Temporal changes following availability of different treatment options in patients with chronic kidney disease and type 2 diabetes (FINEGUST)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• 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

• 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)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  The primary objective of this study is to describe baseline patient characteristics, comorbidities, and comedication of adult patients with CKD and T2D who initiate an SGLT2i, a GLP-1 RA, a MRA, or finerenone in each of 2 time periods corresponding to the finerenone pre-launch and post-launch dates.
• Outcomes:
  • Descriptive summary of baseline patient characteristics ; • Descriptive summary of patient comorbidities ; • Descriptive summary of patient comedications, ; • Descriptive summary of changes over time in treatments in the new-user cohorts ; • Descriptive summary of temporal changes in the baseline characteristics of medication-specific cohorts
• Data analysis plan:
  Descriptive analyses of patient characteristics and treatment patterns.