FINE-REAL: Non-interventional study to collect real-world data and providing insights into the use of finerenone in routine clinical practice

Study type

• 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:
  Diabetic nephropathy

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 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:
  4500

Study design details

• Main study objective:
  The primary objective in this study is to describe treatment patterns in participants with CKD and T2D treated with finerenone in routine clinical practice.
• Outcomes:
  1.Descriptive analysis of clinical characteristics of participants with CKD and T2D. 2.Descriptive summary of reasons for introducing & discontinuation of finerenone 3.Planned and actual duration of treatment with finerenone 4.Descriptive summary of dose & frequency of finerenone treatment. 5.Descriptive summary of secondary therapies used in participants with CKD and T2D, 1.Occurrence of adverse events (AEs) and serious adverse events (SAEs) 2.Occurrence of hyperkalemia, - leading to permanent study drug discontinuation. - leading to dialysis - leading to hospitalization
• Data analysis plan:
  Statistical analyses will be of explorative and descriptive nature. The study is not intended to test pre-defined statistical hypotheses. All variables will be analyzed descriptively with appropriate statistical methods. All analyses will be performed for the total study population (overall population) and separately for each participating country if patient numbers are sufficient and if required for local reasons. All analyses will be performed for the total study population (overall population) and separately for each participating country if patient numbers are sufficient and if required for local reasons. Interim analysis will consist of demographic and baseline data of patients enrolled as well as available safety data.