Burden of AV GRAft and Fistula Complications in chronic kidney disease patients (GRAFIC)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, prospective, international, multicenter longitudinal, comparative cohort study

Study drug and medical condition

• Medical condition to be studied:
  Chronic kidney disease

Population studied

• 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)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  1183

Study design details

• Main study objective:
  The overall objective of the study is to longitudinally evaluate current standard of care and health care utilization, treatment patterns and related costs associated with VA complications in patients with chronic kidney disease Stage 4 or higher requiring an AV graft or fistula for haemodialysis
• Outcomes:
  Evaluation of current standard of care and health care utilization, treatment patterns and related costs associated to VA complications, Baseline sociodemographic and clinical characteristics of patients will be compared according to the presence of any VA complications during the study follow-up period
• Data analysis plan:
  The analyzed population will include all patients recruited to the study who meet all inclusion and no exclusion criteria. A description of the study patients’ sociodemographic and clinical characteristics will be reported according to the study cohorts.The rate of complications for each study group in USA and EU patients will be calculated using a CI of 95%. Types of VA complications will be also reported by study cohorts in USA and EU patients.In the cohort of patients with a maturing fistula, the percentage of fistulae reaching maturation, the failure rate during maturation period, reasons and timing for failure or complications, and the time elapsed between access creation and the initiation of the dialysis will be described.