Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients

Inclusion Criteria: 1. Patient's signed informed consent obtained prior to any study-related procedure; 2. Adult men and women at least 18 years of age with end-stage renal disease who are recipients (or will be recipients) of a kidney transplant from a living or deceased donor; 3. No known contraindications to the administration of tacrolimus, other macrolides and study drugs excipients; 4. Patients must agree to use a highly reliable method of birth control; 5. Donor-recipient negative cross match test, and compatible AB0 blood type; 6. Able to swallow tablets and capsules Exclusion Criteria: 1. Recipient of any transplanted organ other than kidney; 2. Recipient of a previous renal transplant; 3. Recipient of a kidney from a donor after cardiac death; 4. Recipient of a kidney from an AB0 incompatible or positive cross-match donor; 5. Current (not older than 3 months) anti-HLA Panel Reactive Antibody (PRA) levels higher than 30%. Whenever PRA, either complement-dependent cytotoxicity-PRA or calculated PRA , is not available, patients who are positive on solid-phase screening assay for anti-HLA antibodies must not be enrolled; 6. Recipient of a kidney with a cold ischemia time of ≥ 30 hours; 7. White blood cells count ≤ 2.8x109 cells/L unless ANC \>1.0x109/L; 8. Platelet count \< 50 x109 cells/L; 9. ALT or AST levels \>3 times the normal upper limit during the 30 days prior transplant procedure; 10. Current abuse of drugs or alcohol; 11. Incapable of understanding purpose and risk of study, unable to give written informed consent or unwilling to comply with study protocol; 12. Treatment with any other investigational agent in the 30 days prior to enrolment; 13. Kidney recipients and/or donors positive for HCV (HCV-RNA positive or HCV-Ab positive respectively); 14. Kidney recipients and/or donors positive for HBV (HBV-DNA or HBS-Ag positive); 15. Recipients positive for HIV; 16. Patient or donor with current diagnosis or history of malignancy within the past 5 years except basal or non-metastatic squamous cell carcinoma of the skin successfully treated; 17. Uncontrolled concomitant infection, systemic infection requiring treatment or any other unstable condition that could interfere with study objectives; 18. Severe diarrhoea, vomiting, active peptic ulcer or GI disorder that may affect absorption of tacrolimus; 19. Known hypersensitivity to tacrolimus other macrolides and study drugs excipients; 20. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use reliable methods of contraception