Stable Trough Levels but Significant Reduction of the Area Under the Curve of Tacrolimus in Renal Transplanted Patients Converted From Associated Mycophenolate Mofetil to Equimolar Doses of Enteric-Coated Mycophenolate Sodium

Abstract

the patients were still on MMF and 70% on steroids. In the four arms, the mean GFR change over the 2nd and 3rd year was between +1 and -3 ml/min. At 3 years, the low-dose tacrolimus arm still had the highest GFR, although the difference was not signifi cant (68 vs 62-65 ml/min, p = 0.10). Over the 2nd and 3rd years all arms had low rates of biopsy-proven acute rejection (BPAR; 1-3%) and graft loss (3-6%). Non-fatal cardiovascular events were rare (42 cases in total until month 36): 5.2% in the standard-dose CsA, 5.5% in the low-dose CsA 2.4% in the low-dose tacrolimus, and 4.6% in the low-dose sirolimus group. Conclusions: Observational follow-up results based on approximately half of the core Symphony population indicate that during the 2nd and 3rd years renal function was stable, BPAR and graft loss rates were low, and many patients changed treatment regimen. The ITT arm with 2 g MMF + low-dose tacrolimus + daclizumab + steroids still resulted in highest renal function and lowest graft loss at 3 years, but these differences were not statistically signifi cant.