Primary endpoint
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SECONDARY
The aim of the EnGraft Study is to show that Envarsus® is superior to Advagraf™ with respect to the primary variable, which is defined as the C/D ratio at week 12 after randomisation.The analysis of the primary endpoint will be performed by means of analysis of covariance considering randomised treatment and pre-treatment with immediate-release tacrolimus (stratification factor) as fixed effects in the model. Least square means, standard errors, treatment difference and corresponding 95% confidence intervals will be reported.The primary population for analysis of the primary endpoint, secondary efficacy endpoints and secondary pharmacokinetic endpoints will be the FAS. Supportive analyses will be carried out for the PPAS.