Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients (ELEVATE)

Inclusion Criteria at Baseline:

• Male or female renal allograft recipients at least 18 years old.
• Written informed consent.
• Patient receiving a primary or secondary kidney transplant from a cadaveric or living unrelated-/related donor.
• Cold ischemia time (CIT) < 24 hours.
• Negative pregnancy test for female patients.

Inclusion Criteria at Randomization:

• Patients on CNI (TAC or CsA) + Myfortic + steroids.
• Serum creatinine < 2.8 mg/dL (250 µmol/L) and an actual eGFR (MDRD4) ≥ 25 mL/min/1.73m exp2 (without renal replacement therapy).

Exclusion Criteria at Baseline:

• Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
• Recipient of multiple organ transplants.
• Recipient of ABO incompatible allograft or a positive cross-match.
• Panel Reactive Antibodies (PRA) level ≥ 30 %.
• Positive test for human immunodeficiency virus (HIV).
• Patient receiving 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 LFTs (ALT/AST levels ≥ 2.5 times ULN).
• Severe restrictive or obstructive pulmonary disorders.
• Patient with severe allergy requiring acute or chronic treatment or hypersensitivity to any of the study drugs or similar drugs.
• Severe hypercholesterolemia or hypertriglyceridemia.
• Low platelet count.
• Low white blood cell count.
• History of malignancy of any organ system

Exclusion Criteria at Randomization:

• Graft loss.
• Patient on renal replacement therapy.
• Patient who experienced severe humoral and/or cellular rejection (BANFF ≥ IIb).
• Patient with ≥ 2 episodes of AR or an AR episode that needed antibody treatment.
• Patient with ongoing or currently treated AR (2 weeks prior to randomization).
• Proteinuria > 1 g/day.
• Patients with recurrence of Focal Segmental Glomerulosclerosis (FSGS).
• Low platelet count; Low white blood cell count; Low absolute neutrophil count; Low hemoglobin.
• Severe liver disease.
• Systemic infection requiring continued therapy that would interfere with the objectives of the study.
• Severe hypercholesterolemia or hypertriglyceridemia.
• Patients with ongoing wound healing problems, clinically significant infection requiring continued therapy.
• Presence of intractable immunosuppressant complications or side effects.
• Patients on anticoagulants that prevents renal allograft biopsy.
• Use of prohibited medication.
• Use of immunosuppressive agents not utilized in the protocol.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential not using a highly effective method of birth control.