A regulatory non-interventional study to monitor the safety and efficacy of JARDIANCE® (Empagliflozin 10 mg) in Korean patients with Chronic Kidney Disease (CKD)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Study drug and medical condition

• Name of medicine:
  JARDIANCE
• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK03) empagliflozin

  empagliflozin
• Medical condition to be studied:
  Chronic kidney disease

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)
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  To monitor the safety profile and efficacy of JARDIANCE® in Korean patients with CKD in routine clinical practice
• Outcomes:
  The primary outcomes are the safety outcomes calculated as the incidence of AEs, SAEs, non-SAEs, ADRs, serious ADRs, unexpected AEs, AESIs, etc. Change in UACR from baseline after 12 weeks and/or 24 weeks of treatment
• Data analysis plan:
  All statistical analyses will be explorative in nature. ; Participant characteristics will be reported using measures of central tendency (e.g. mean, median) and variance (standard deviation, quartiles) for continuous variables and using frequencies and percentages for count data. Frequency of safety events will be reported using frequencies and incidence with 95% confidence interval (CI). ; The changes of the efficacy outcomes from baseline will be compared in an exploratory sense via paired t-test.