Post Marketing Surveillance on Long Term Use of JARDIANCE® Tablets in Patients with Chronic Kidney Disease in Japan

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

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

• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  1000

Study design details

• Study design:
  Cohort study; Non-interventional, single arm study based on newly collected data Patients will be observed for up to 52 weeks after the start of the treatment with JARDIANCE® Tablets or until discontinuation of administration.
• Main study objective:
  Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with CKD under real-world use.