The purpose of this study is to demonstrate the efficacy and safety in the use of everolimus, with its onset after 3 months of treatment with calcineurin inhibitor.
The patient who met the inclusion and exclusion criteria will be included in the study and randomized into two groups in the third month post transplant, they will be in use of tacrolimus, corticosteroids and Mycophenolate sodium. The group 1 will undergo a conversion from calcineurin inhibitor to Everolimus within 1 day (overnight), group 2 will be maintained with the initial immunosuppression. We will start Everolimus at 1 mg 2x/day and three days after the beginning we will adjust the dose by the serum levels, which will be kept in 6 to 10ng/dL. The doses of corticosteroids and Mycophenolate sodium will be retained. There will be performed renal biopsies at randomization and after 12 months. The glomerular filtration rate will be calculated monthly using the MDRD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Group will switch calcineurin inhibitor to everolimus within 1 day (overnight).
Group will maintain their initial immunosuppression therapy with calcineurin inhibitor
Hospital federal de Bonsucesso
Rio de Janeiro, Rio de Janeiro, Brazil
Change from Baseline in Creatinine Clearance at 24 months
The primary objective is to demonstrate the effectiveness and non-inferiority of treatment with everolimus, by assessing renal function, in comparison with the use of calcineurin inhibitor.
Time frame: baseline and two years
Number of Participants with Adverse Events
The secondary objective is to demonstrate the safety by comparing rejection episodes, graft loss, infection, cancer and death in the control group
Time frame: baseline and two years
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