Status: Planned First registered on: 26/11/2020
Last updated on: 11/12/2020
1. Study identification
EU PAS Register NumberEUPAS38308
Official titleComparative Effectiveness and Safety of Immunosuppressive Drugs in Transplant patients
Study title acronymCESIT
Study typeObservational study
Brief description of the studyCESIT is an Italian multicenter retrospective cohort study on the use of immunosuppressive drugs in transplant patients, based on information available in regional administrative healthcare databases and on National Transplant Information System (SIT). The aims are: 1) to describe the prescriptive patterns of immunosuppressive drug regimens in different transplant settings (kidney, lung, liver, heart) used in maintenance phase and to identify patient characteristics associated to these patterns in the four Italian regions (Lombardy, Veneto, Lazio, Sardinia), accounting for over 20 million residents; 2) to compare the risk-benefit profile of different immunosuppressive therapeutic regimens, with a focus on generics/branded and special populations (paediatric and elderly) 3) to evaluate data validity and generalizability through SIT All transplant patients residing in the regions involved in the study will be identified through an algorithm considering all the hospitalizations, occurred over the years 2009–2019, reporting a transplantation procedure . Comorbidity will be defined from Hospital discharge records (ICD-9-CM codes), disease specific copayment exemptions, and, as far as possible, disease specific drug treatments and NTIS. Drug utilisation patterns will be based on drugs (ATC codes) prescribed to outpatients using the DDDs. Specific outcomes, such as organ survival and rejection, will be identify by SIT. Safety and effectiveness will be investigated using a new-user approach and applying both, intention-to-treat and as-treated analysis. Data and analysis will be managed through a common data model, with shared data scripts, performing the analysis and pooling aggregated anonymous data to obtain overall results.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsDepartment of Epidemiology Lazio Region, Italy
Department/Research groupDepartment of Epidemiology
Organisation/affiliationLazio Regional Health Service
Website/Homepagewww.deplazio.net
Details of (Primary) lead investigator
Title Ms
Last name Belleudi
First name Valeria
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7

Department of Epidemiology Lazio Region, Italy
National transplant center (CNT), National Institute of Health, Rome, Italy
Pharmacoepidemiology Unit, National Centre for Drug Research and Evaluation, National Institute of Health, Rome, Italy
Epidemiology Observatory - Department of Health of Lombardy Region, Milan, Italy
Department of Diagnostics and Public Health, Section of Pharmacology, University of Verona, Verona, Italy
Epidemiological Department, Azienda Zero, Veneto Region, Padua,Italy
Regional Councillorship of Health 'Regione Autonoma della Sardegna', Cagliari, Italy
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed23/09/202023/09/2020
Start date of data collection01/02/2021
Start date of data analysis01/03/2021
Date of interim report, if expected23/09/2021
Date of final study report30/09/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyItalian Medicines Agency12
Research councils
EU funding scheme
OtherRegional Drug Departments88
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Belleudi
First name Valeria
Address line 1Via Cristoforo Colombo, 112
Address line 2 
Address line 3 
CityRoma 
Postcode00147 
CountryItaly
Phone number (incl. country code)39-06-99722160 
Alternative phone number 
Fax number (incl. country code) 
Email address v.belleudi@deplazio.it
Public Enquiries
Title Ms 
Last name Belleudi 
First name Valeria 
Address line 1Via Cristoforo Colombo, 112 
Address line 2 
Address line 3 
CityRoma 
Postcode00147 
CountryItaly 
Phone number (incl. country code)39-06-99722160 
Alternative phone number 
Fax number (incl. country code) 
Email address v.belleudi@deplazio.it 
Top