Non-inferiority hypothesis
The primary objective is to demonstrate the non-inferiority of TTV-guided immunosuppression (arm T) compared to standard dosing (arm S) in stable adult kidney transplant recipients with low immunological risk in the first year after transplantation. Non-inferiority can be concluded if the upper limit of a two-sided 95% CI for the difference in proportion of patients at month 9 after randomisation (= Visit 7; post-transplant month 12) between the two treatment arms is less than 10% points. Let pT and pS be the proportion (in %) of participants in the arm T and arm S, respectively, then the primary statistical hypothesis can be formulated as follows: