Sample size calculation
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Sample size estimation is based on testing superiority of Envarsus® versus Advagraf™ with respect to the primary efficacy variable. C/D ratio data obtained from previously published clinical trials in kidney transplantation and observational studies in LTx inform an assumed difference between the two treatments Envarsus® or Advagraf™ after 12 weeks of approximately 0.4 with a standard deviation of 1.0.A sample size of 100 patients per treatment group will have the power of 80% to show a difference of 0.4 in C/D ratio between the two treatment groups with a two-sided significance level of 5%. The primary test will be performed based on the Full Analysis Set (FAS) but will be repeated for the Per-protocol analysis set (PPAS). To have a sufficient power also for the PPAS comparison, it is planned to randomise 134 patients in each treatment group assuming that about 25% of randomised patients cannot be included in the PPAS because of major protocol deviations. A sample size of 134 patients per treatment group will have a 90% power to show a difference of 0.4 in C/D ratio in the FAS. The minimal detectable difference in the FAS will be 0.24.