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:
  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:
  Inclusion criteria-; - Patients with CKD who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and who provided written informed consent prior to enrolment in this study.; - Patients who have never been treated with Empagliflozin (including treatment for T2DM ; and CHF) before enrolment.
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  1.000

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.
• Outcomes:
  -Kidney disease progression (defined as incidence of ESKD, a sustained decline in eGFR to <10 mL/min/1.73m2, renal death, or a sustained decline of ≥40% in eGFR from baseline); -Cardiovascular death; -All cause death; -Hospitalization for heart failure; -Change from baseline in eGFR to the last observation on treatment