Renal Transplantation Clinical Trial
Official title:
Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I
This is a prospective, multicenter, observational, non -interventional study with comparison
with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin
(Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation
by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA
occurrence and toxicities, various infections including CMV and BK virus incidence, MACE
(major cardiac adverse event) and cancer.
Investigators will also compare cumulative treatment and follow up costs and other key
criteria available in the ASTRE database.
This is a prospective, multicenter, observational, non -interventional study with comparison
with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin
(Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation
by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA
occurrence and toxicities, various infections including CMV and BK virus incidence, MACE
(major cardiac adverse event) and cancer.
Investigators will also compare cumulative treatment and follow up costs and other key
criteria available in the ASTRE database.
Justification for a non-interventional study: in the study the medicinal products will be
prescribed in the usual manner in accordance with the terms of the marketing authorisation.
The assignment of the patient to the product is not decided in advance by a trial protocol
but falls within current practice of the centre and the prescription of the medicine is
clearly separated from the decision to include the patient in the study. No additional
diagnostic or monitoring procedures are applied to the patients and epidemiological methods
are used for the analysis of collected data.
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