Study identification

EU PAS number

EUPAS38308

Study ID

41064

Official title and acronym

Comparative Effectiveness and Safety of Immunosuppressive Drugs in Transplant patients (CESIT)

DARWIN EU® study

No

Study countries

Italy

Study description

CESIT 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.

Study status

Ongoing
Research institutions and networks

Institutions

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

Contact details

Valeria Belleudi

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
Other

More details on funding

Italian Medicines Agency, Regional Drug Departments
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable