One Agent-Once a Day: 2 Year Outcomes of a Prospective Randomized Trial of Once Daily (Extended Release) Tacrolimus Maintenance Monotherapy vs Twice Daily (Standard Release) Tacrolimus After Alemtuzumab Induction & Early Steroid Cessation (TAESR Trial). Rejection and Variation in Tacrolimus Levels.

Abstract

Introduction: The availability of once-daily extended-release tacrolimus (Advagraf), provides the opportunity to develop a one-agent, once-a-day, maintenance immunosuppressive regimen from the well established combination of tacrolimus monotherapy after alemtuzumab induction with early steroid cessation. Methods: We have undertaken a prospective, randomized, controlled trial comparing graft and patient outcomes, and tacrolimus trough level intra-patient variability with once vs twice daily tacrolimus monotherapy (n=52 vs 50 patients). Results: At 2 years post-transplant, patient survival, graft survival, and the incidence of all rejection (biopsy proven acute cellular, and acute and chronic antibody mediated) did not differ significantly between the two arms:Table: No Caption available.Intra-patient variability (coefficient of variation) of tacrolimus levels did not differ significantly between the two groups, although after the first year post-transplant there was a trend to increased variability in the twice daily, standard release group, and decreasing variability in the once daily, extended release group.Figure: No Caption available.Conclusions: Once daily extended release tacrolimus provideds safe and effective maintenance monotherapy after alemtuzumab induction and early steroid cessation, with graft and patient survival, and rejection levels comparable to twice daily, standard release tacrolimus. DISCLOSURES:McLean, A.: Grant/Research Support, Astellas pharma UK.