Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Healthcare resource utilisation
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

ADVAGRAF

Study drug International non-proprietary name (INN) or common name

TACROLIMUS

Anatomical Therapeutic Chemical (ATC) code

(L04AD02) tacrolimus
tacrolimus
Population studied

Short description of the study population

The people in this study will have had a kidney transplant from a donor under 50 years of age (standard criteria donor), or over 50 years of age (expanded criteria donor). They had their kidney transplants between 2008 and 2014 and were treated with ADVAGRAF.

Age groups

  • Adult and elderly population (≥18 years)

Estimated number of subjects

180
Study design details

Study design

This study is a secondary data project designed as a retrospective, non-interventional, observational, multi-center chart review conducted in adult patients, who underwent standard criteria donor or expanded criteria donor kidney transplant and received ADVAGRAF-based therapy.

Main study objective

The main aim of this study is to collect information about the long-term outcomes of kidney transplants treated with ADVAGRAF in Europe. Researchers will also learn how factors like sex, age, bodyweight, and other treatments might affect transplant outcomes.

Comparators

N/A

Outcomes

1. Patient survival: Time to death, Cumulative mortality at the end of follow-up.
2. Graft survival: Time to graft failure, Cumulative incidence of overall graft failure at the end of follow-up, Time to death-censored graft survival, Cumulative incidence of death-censored graft failure at the end of follow-up.