Eligibility NCT01363752 Kidney Transplantation Inclusion Criteria Exclusion Criteria Receiving or having previously received an organ transplant other than a kidney Yes
No
Cold ischemia time of the donor kidney > 30 hours Yes
No
Panel-reactive antibody Yes
No
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest) Yes
No
Significant liver disease, defined as having continuously elevated SGPT/ ALT and/ or SGOT/ AST and/ or total bilirubin levels >= 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor Yes
No
Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s) Yes
No
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy) Yes
No
Significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer Yes
No
Pregnant woman or breast-feeding mother Yes
No
Subject or donor known to be HIV positive Yes
No
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine Yes
No
Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers Yes
No
Currently participating in another clinical trial, and/ or has taken an investigational drug within 28 days prior to enrollment Yes
No
Unlikely to comply with the visits scheduled in the protocol Yes
No
