Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Inclusion Criteria: * Female subject of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to maintain effective birth control during the study * Has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation * Subject is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible AB0 blood type Exclusion Criteria: * Pregnant woman or breast-feeding mother * Has an immunological high risk, defined as having a most recently measured PRA grade of \> 50% within the previous six months * Known allergy to the study drug or any of its components * Requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation * Requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s) * Subject or donor is known to be HIV positive * Has significant liver disease, defined as having during the past 28 days continuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site * Diagnosis of malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully * Has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer * Previously received or is receiving an organ transplant other than kidney * Receiving a graft from a non-heart-beating donor * Cold ischemia time of the donor kidney \>30 hours * Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator