| Outcome Measures: |
Primary: Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria)., Protocol kidney biopsies collected at approximately 12 and 24 months were scored by a transplant renal pathologist blinded to treatment group assignment for evidence of rejection, BK virus nephropathy, antibody-mediated rejection, recurrent disease, inflammation, and Banff 2005 categories of chronic renal injury. Chronic injury categories were arteriolar hyaline thickening (ah), allograft glomerulopathy (cg), interstitial fibrosis (ci), tubular atrophy (ct), and vascular fibrous intimal thickening (cv). Severity scores within each category could be 0 (\<5%; none or minimal), 1 (\>5% - \<25%; mild), 2 (\>25% - \<50%, moderate), or 3 (\>50%, severe). The proportions of patients in each severity grade (0, 1, 2, and 3) for both the individual categories and a composite were compared using Fisher's exact test., Two years|Average of Renal Function, Calculated Glomerular Filtration Rate (GFR) by using the abbreviated MDRD (aMDRD) formula and patient serum creatinine and demographic data; averaged values from months four through 24., Two years | Secondary: Safety Profile, Number of events: cytomegalovirus (CMV) disease, opportunistic infections (bacteremia, abscess, pneumonia, fungal), Post-transplantation Lymphoproliferative Disorder (PTLD), wound healing problems within 30 days, and lymphoceles., Two years|Requirement for Additional Immunosuppression (Such as Corticosteroids, Antimetabolites or Other Immunosuppressive Agents), Two years|Acute Rejection Per Kidney Biopsy (Banff Grading Criteria), Two years|Acute Tubular Necrosis (ATN) Rate, Defined as the Requirement for Dialysis Within 7 Days Post-transplantation., Seven days|Graft Survival, Graft failure = permanent return of patient to dialysis., Two years|Patient Survival, Two years|Lymphoid Cell Sub-type CD3 Absolute Numbers, One year|New-onset Polyomavirus (BK Virus) Disease Per Kidney Biopsy, Two years|New-onset Diabetes and Hyperglycemia After Transplantation (NODAT), Six months|Ratio of CD4/CD8 Lymphoid Cells, One year
|
