Evaluation of Calcineurin-inhibitor Reduction With Conversion at 2 Months to Everolimus/Reduced Tacrolimus in Renal Transplant Recipients Following Campath® Induction

Exclusion Criteria

• •Recipient of ABO incompatible allograft or a positive cross-match.
• •Patient who is human immunodeficiency virus (HIV) positive.
• •Patient who received an allograft from a Hepatitis B surface Antigen (HBsAg) or a Hepatitis C Virus (HCV) positive donor.
• •HBsAg and/or a HCV positive patient with evidence of elevated liver function tests (LFTs) (Alanine transaminase/Aspartate transaminase \[ALT/AST\] levels ≥ 2.5 times upper limit of normal \[ULN\]). Viral serology results obtained within 6 months prior to randomization are acceptable.
• •Patient with severe restrictive (total lung capacity \[TLC\] \< 50%) or obstructive pulmonary (forced expiratory volume in one second \[FEV1\] \< 50) disorders.
• •Patient with severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment that would prevent patient from potential exposure to everolimus, or with hypersensitivity to drugs similar to everolimus (e.g. macrolides).
• •Patients with a known hypersensitivity/contraindication to any of the immunosuppressants or their classes, or to any of the excipients.
• •Patient with severe hypercholesterolemia (\> 300 mg/dL) or hypertriglyceridemia (\> 400 mg/dL) that cannot be controlled despite lipid lowering therapy.
• •Patient with white blood cell (WBC) count ≤ 1,000 /mm3 (and absolute neutrophil count \[ANC\] of \<500) or a platelet count ≤ 50,000 /mm3.
• •History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. (Localized basal cell carcinoma of the skin at any time, or small (less than 4 cm) or low-grade renal cancers, bladder cancers, or treated prostate cancer with no evidence of disease after 2 years are allowable)
• •Graft loss.
• •Patient on renal replacement therapy.
• •Patient who experienced biopsy proven rejection.
• •Proteinuria \> 1 g/day (as calculated from the urinary protein-to-creatinine ratio).
• •Patients with recurrence of Focal Segmental Glomerulosclerosis (FSGS).
• •Patient who has a current severe systemic infection according to the investigator judgment requiring continued therapy that would interfere with the objectives of the study.
• •Patients with ongoing wound healing problems, clinically significant infection requiring continued therapy or other severe surgical complication in the opinion of the investigator.
• •Presence of intractable immunosuppressant complications or side effects.
• •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (\>5 mIU/mL)
• •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods.