ESTEROID WITHDRAWAL STUDY, SAFETY AND EFFICACY IN RENAL TRANPLANTATION
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
BACKGROUND: Non-steroid maintenance immunosuppression after transplantation can improve
long-term lipid and hemodynamic profiles without severe acute rejection (AR) events that
alter graft function or survival. Our objective was to evaluate the effects of early steroid
withdrawal (ESW) on the frequency and severity of AR using an immunosuppressive scheme
consisting of mycophenolate (MMF) and tacrolimus (TAC) in combination with an induction
treatment with basiliximab.
METHODS: A randomized clinical trial was performed on first renal transplant recipients. In
the ESW group, patients were selected for corticosteroid treatment withdrawal on the fifth
day post-transplantation. In the Control group, patients continued steroid treatment.
Phase:
Phase 4
Details
Lead Sponsor:
Unidad de Investigacion Medica en Enfermedades Renales