Effects of the Quadruple Immunosuppression on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Kidney Transplant

Evaluation of the Effects of Sirolimus Addition to the Triple Immunosuppression Protocol on Peripheral Blood Lymphocytes and Development of Anti-HLA Antibodies in Sensitized Kidney Transplant Recipients - a Pilot Study

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.

Inclusion Criteria:

• Men and women, ages 18 to 60 years inclusive
• Percentage of Panel Reactive Antibodies at transplantation > 20%
• Estimated glomerular filtration rate using MDRD formula at inclusion >29ml/min

Exclusion Criteria:

• Subjects with a history of cancer
• Subjects with a previous non kidney transplantation
• Subjects receiving any immunosuppression different of tacrolimus/prednisone/mycophenolate
• Subjects with a urinary protein/creatinine ratio greater than 0.3
• Subjects with active HBV, HCV and HIV infection