Rapamycin and Regulatory T Cells in Renal Transplant Patients: a Two-year Randomized Prospective Study
It is two years randomised controlled trial in parallel groups.
It has been resolved to compare different immunosuppressive regimens:
1. cyclosporine+ mycophenolate+prednisone
2. rapamycin + mycophenolate + prednisone, this treatment should be introduced after one
month from renal transplantation.
Patient should visited at month 1-6-12-24 from the transplant. During the control we will
reported the following data: physical examination, blood test (blood count, creatinin, BUN,
immunosuppressive blood concentration, histological response of surveillance renal biopsy),
blood pressure, attendant change of current therapy, pathological variation, or any
hospitalisation both ordinary or in DH regimen.
Moreover in all control visit it will be collected a blood sample for evaluation of
regulatory t cells.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The absolute number of T-reg after renal transplant in patients in treatment with rapamycin compared to patients treated with cyclosporine
Every 6 months after the transplantation
Antonio Dal Canton, MD
Policlinico Fondazione IRCCS "San Matteo", Pavia
Italy: Ethics Committee