ABOUT THIS STUDY
1. Absence of clinical acute rejection in post-transplant period preceding randomization
2. HLA-mismatched solitary first and second kidney transplant recipients
3. Absence of any degree of rejection (Banff 2007) on renal biopsy at 3-6 months(+/- 2 months) post-transplant.
4. Absence of post-transplant donor-specific antibody
1. HLA-identical transplants
2. Contraindication or inability to undergo renal biopsy, like previous complications due
to biopsies, anticoagulation, active infection, etc.
3. Positive flow cross match, sensitized recipient, presence of donor-specific antibody.
4. Rejection episode after transplantation, either cellular or humoral on for cause or
5. Rejection present on pre-randomization renal biopsy.
6. Proteinuria greater than 0.3 gram/day
7. Native kidney disease biopsy proven or likely glomerulonephritis, primary or recurrent
FSGS, MPGN or primary or recurrent membranous GN.
8. Hypertriglyceridemia > 400 mg/dL (treated), LDL cholesterol > 160 mg/dL while on
9. WBC < 2000/mm3, ANC < 1000 mm3, Platelet count < 100,000 mm3
10. Active wound issues.
11. Primary non-function.
12. Active BKV or CMV disease.
13. Evidence of recurrent disease.
14. Active infection
16. Women of childbearing potential unable or unwilling to use birth control during the
17. e GFR ≤ 40 ml/ min at screening
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