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
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  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

• Short description of the study population:
  Patients diagnosed with CKD in Korea.
• 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)
• Estimated number of subjects:
  250

Study design details

• Study design:
  Single-arm, open-label, multi-centre, observational and non-interventional study based on newly collected data
• Main study objective:
  To monitor the safety profile and efficacy of JARDIANCE® in Korean patients with CKD in routine clinical practice
• Setting:
  Approximately 20 sites with approximately 20 or more investigators will participate in the study. To minimize selection bias at the site level, the goal is to have participating centers reflect a balance between general hospitals and clinics. The investigators will be mainly internists or nephrologists.
• 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.