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.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.