The purpose of this study is to determine the effects of sirolimus in the phenotype of peripheral blood T and B lymphocytes regarding their naïve, memory, effector end regulatory phenotype and in the development of anti-HLA antibodies among kidney transplant recipients with high immunological risk for graft rejection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid.
Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
RECRUITINGA composite of graft loss and/or death with graft function
Time frame: up to one year
Number of participants with serious and non-serious adverse events and the incidence of biopsy proven acute allograft rejection
Time frame: Up to one year
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