Association of eGFR slope and cardiovascular/renal events or all-cause deaths in Japanese database (eGFR slope and death)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Chronic kidney disease

Population studied

• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • 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:
  30000

Study design details

• Main study objective:
  Primary objective: to assess the association between the annual rate of eGFR change with CV/renal events and all-cause mortality, adjusting for age, sex, CV medical history and baseline eGFR and/or UACR value
• Outcomes:
  all cause and cardiovascular mortality, myocardial infarction, stroke, and congestive heart failure.
• Data analysis plan:
  1. Patient background: descriptive statistics will be provided on the age, sex, presence of medical history Elixhause comorbidity index score and prescription of CV related medication by class during the baseline period. Sex, medical history, and CV related medication will be described as percentages to all eligible patients. 2. Slope of eGFR: descriptive analysis will be provided on the annual decline of eGFR overall (mean, 95% CI) and stratified by patients experiencing cardiovascular/renal and in-hospital mortality. The least square regression method will be used to calculate the slope and its 80%CI. Based on the slope all patients will be categorized into six groups3. Cox proportional hazards model will be applied to ②－⑥category of patients with ① as the reference group with time to event analysis conducted for each outcome.