Wednesday 18 August 2010 Clinical Trials of Immunosuppression 1320 THE TRANCEPT TRIAL – FINAL STUDY RESULTS DEMONSTRATE BENEFITS FROM INTRODUCTION OF MYCOPHENOLATE MOFETIL (CELLCEPT®) SEVERAL YEARS AFTER TRANSPLANTATION. H.U. Meier-Kriesche1, U. Heemann2, P. Merville3, H. Tedesco-Silva4, J. Ferraris5, C. Bernasconi6 1 Medicine, University of Florida, Gainesville/FL/UNITED STATES OF AMERICA, 2Department Of Nephrology, Klinikum rechts der Isar der technischen Universität München, München/GERMANY, 3, Hopital Pellegrin, Bordeaux/FRANCE, 4, Hospital do Rim e Hipertensao, Sao Paulo/BRAZIL, 5Pediatric Nephrology, Hospital Italiano, Buenos Aires/ ARGENTINA, 6, Hoffmann-La Roche Ltd., Basel/SWITZERLAND Introduction: There is evidence for long-term benefits of mycophenolate mofetil (MMF) in renal transplantation, but the effect of introducing MMF at different times post-transplant and for different reasons has not been studied in detail. Here we report the final results of TranCept, a large multinational observational study. Methods: TranCept was a 4 year prospective, multicenter observational clinical study of patients in whom MMF was introduced at more than 6 months following transplantation. The primary objective was to document renal function up to 4 years after MMF introduction. We assessed the time course of estimated GFR (4-variable MDRD formula) by descriptive methods and modified linear breakpoint analysis. Multivariate regression analyses were performed on factors affecting the course of GFR and graft loss. Results: In the 2087 evaluable patients, the main reason for introducing MMF was renal function decline (43%), followed by tolerability problems with previous treatment (23%). CNI was reduced or withdrawn in 40% of the patients after MMF introduction. Mean GFR at -4, 0 and 4 years from MMF introduction was 56, 49 and 48 ml/min respectively. For the whole population, the slope change at MMF introduction was 2.01 ml/min/year with a positive slope following MMF introduction (p<0.001). MMF introduction was effective early as well as late after transplantation. Slope change was 1.59 ml/ min/year for the group with MMF introduction 5 years or more after transplantation (median: 9 years). GFR of patients who started taking MMF due to adverse events increased moderately (0.94 ml/min/year). The slope change was larger for patients who introduced MMF due to declining renal function and in whom CNI was reduced or withdrawn (3.09 ml/min/year). 340 A multivariate analysis yielded CNI reduction as the treatment-related predictor of improved GFR after MMF introduction with the highest significance (p=0.002). MMF dose (p=0.012) and use of Tacrolimus (p=0.023) also had positive association with improved GFR. Less quickly deteriorating renal function before MMF introduction, low mean pre-MMF GFR value and proteinuria were inversely associated with improved GFR (p<0.001). In a cohort of patients on MMF since transplantation (no MMF introduction at enrollment), we observed virtually no change in GFR slope. No major tolerability or acute rejection problems emerged after MMF introduction and survival of patient and graft was 91% at 4 years after enrollment. Cox regression identified proteinuria, low hemoglobin, renal function decline, time after transplantation and male gender as risk factors for graft loss or death. Conclusion: MMF introduction may be beneficial for renal function even several years after transplantation, particularly in patients with declining renal function and when associated with judicious CNI minimization or withdrawal. Disclosure: All authors have declared no conflicts of interest. Supplement to Transplantation July 27, 2010, Volume 90 Number 2S