Absence of Steroid in Renal Transplantation and Digital Fibrosis Observation
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
The main objective of this study is to demonstrate that the absence of post-transplantation
corticosteroids does not induce a larger increase of renal graft fibrosis (by numerical
reading) on biopsy at one year post-transplantation than immunosuppressive treatment strategy
that includes standard oral corticosteroids.The secondary objectives of the study consist to
compare on various parameters (fibrosis progression, renal function, dialysis, ratio of
proteinuria/creatinuria, acute rejection, donor-specific antibody, graft survival, clinical
and biological tolerance) therapy with no corticosteroids post-transplantation in comparison
to standard immunosuppressive treatment strategies including oral corticosteroids. Secondary
objectives of the study consist also to compare the two techniques for assessing fibrosis by
numerical reading and by centralized blinded reading of the treatment group (by 2 anatomical
pathologists).