Randomisation
SECONDARY
A dynamic allocation technique will be used for randomisation of patients fulfilling the trial eligibility criteria in a 1:1 ratio to one of two treatment arms: Envarsus® tablets (test IMP) or Advagraf™ capsules (comparator IMP). Pre-treatment with immediate-release tacrolimus (Yes/No), as well as trial site, will be used as stratification factors in the treatment allocation to minimise sources of treatment bias. The first stratification factor (study centre) will minimise systematic treatment bias at the study centre level and reduce the influence of inter-centre variability. The second stratification factor (pre-treatment with immediate-release tacrolimus) will minimise treatment bias at the level of the individual patient, since patients treated with Prograf® during the run-in phase can be expected to develop stable trough levels after randomisation more rapidly than patients who do not receive Prograf® prior to commencing IMP. Balancing the treatment arms with respect to this factor allows fair and unbiased evaluation of the secondary pharmacokinetic endpoints that evaluate the ease with which the first target trough level is achieved.The allocation algorithm is programmed into a randomisation module in the trial database. Study investigators at the participating trial sites have access to the randomisation module via the online trial database and randomise using this central tool. It is vital that randomisation is performed as soon as possible after eligibility has been confirmed and no later than 14 days after transplantation surgery; enrolment after this time period is not allowed.