Effects of the Use of "de Novo" Everolimus in Renal Tranplant Population
Status:
Unknown status
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
This is an open, randomized, single-center study. The selected patients will be first divided
into two major groups according to the type of organ to be transplanted: standard criteria
donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to
one of the treatments: tacrolimus (TAC) or everolimus (EVL).
All patients received induction therapy with basiliximab (BXB) and maintenance with
Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary
objectives: To characterize the molecular profile of cytokines in kidneys obtained from
deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before
and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in
the expression of these molecules. And as Secondaries objectives: To correlate the pattern of
cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection
and patient and graft survival.