drugset / Trial / NCT02328222

ESTEROID WITHDRAWAL STUDY, SAFETY AND EFFICACY IN RENAL TRANPLANTATION

NCT02328222

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-06
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisone Other / unclassified 0.1 mg/kg
Background Methylprednisolone Other / unclassified