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