Study of Everolimus in de Novo Renal Transplant Recipients

Evaluation of the Early Conversion From a Calcineurin Inhibitor-based Immunosuppressive Regimen to Everolimus in de Novo Renal Transplant Recipients, a Multicenter Experience

In the present study, the investigators propose a conversion scheme with 50% reduction in CNI dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10 ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes.

The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic® and Certican® significantly improves renal function compared with the standard regimen of CNI.

Inclusion Criteria:

• Renal transplant patients
• Age between 18 and 85 years
• Recipients of living or deceased donors
• Donor under the age of 85 years
• Panel Reactivity Antibodies (PRA) over or equal to 30%
• 4-5 months post-transplant
• CNI-based immunosuppressive regimen
• Stable graft function (creatinine lower than 2.0 mg/dl)
• No currently acute rejection
• Proteinuria lower than 800mg/d
• No laboratory or physical clinically significant signs presented for the last 2 months before screening.

Exclusion Criteria:

• Recipient of multiple organs
• Recipient with a history of focal segmental glomerulosclerosis or membranous glomerulonephritis
• Presence of uncontrolled hypercholesterolemia (≥350 mg/dL)hypertriglyceridemia (over or equal to 500 mg/dL)
• Patients with eGFR lower than 40 ml/min/1.73m2
• Evidence of acute rejection within 2 months before screening
• Thrombocytopenia (lower than 75,000/mm3)
• Neutropenia (lower than 1,500/mm3)
• Leukocytopenia (lower than 2500/mm3)
• Anemia (hemoglobin lower than 6.0g/dL)
• Severe liver disease (including transaminases or bilirubin equal or over 3 times normal)
• Proteinuria over 800mg/dL
• Systemic infection or pneumonia (active infection)
• Positive for Hepatitis B, Hepatitis C or HIV.