Information is lacking concerning concomitant administration of enteric-coated mycophenolate sodium with tacrolimus (EC-MPS+Tac) in renal transplant recipients (RTxR). In this 6-month, prospective, open-label, multicenter study, de novo RTxR were randomized (1？:？1) to low-dose (LD) or standard-dose (SD) Tac with basiliximab, EC-MPS 720？mg bid, and steroids. Primary objective was to compare renal function at 6-month posttransplantation. Secondary objectives were to compare the incidences of biopsy-proven acute rejection (BPAR), graft loss and death, and new-onset diabetes mellitus (NODM). 292 patients (LD , SD ) were included. Mean Tac levels were at the low end of the target range in standard-exposure patients (SD, ) and exceeded target range in low-exposure patients (LD = 151) throughout the study. There was no significant difference in mean glomerular filtration rate (GFR) between treatments (ITT-population: 63.6 versus 61.0？mL/min). Incidence of BPAR was similar (10.6% versus 9.9%). NODM was significantly less frequent in LD Tac (17% versus 31%; ); other adverse effects (AEs) were comparable. EC-MPS+Tac (LD/SD) was efficacious and well tolerated with well-preserved renal function. No renal function benefits were demonstrated, possibly related to poor adherence to reduced Tac exposure. 1. Introduction Mycophenolate mofetil (MMF), a prodrug of mycophenolic acid (MPA), is associated with a high incidence of gastrointestinal (GI) AEs [1, 2]. Enteric-coated mycophenolate sodium (EC-MPS) is an MPA formulation developed to improve MPA-related upper GI side effects by delaying the release of MPA until reaching the small intestine. Clinical trials in renal transplant (RTx) patients have demonstrated therapeutic equivalence between EC-MPS and MMF when administered at equimolar dosages [3–5], and data suggests a reduced GI-related symptom burden and improved patient well-being with EC-MPS treatment compared with MMF [6–8]. However, Phase III trials with both MMF and EC-MPS were all performed in patients on a cyclosporine (CsA) microemulsion-based immunosuppressive regimen; there is limited experience with the use of EC-MPS in combination with tacrolimus (Tac). It has been shown that conversion of Tac-treated maintenance RTx patients from MMF to EC-MPS was well tolerated without compromising efficacy [9], but more rigorous data is required on efficacy and safety of EC-MPS with Tac. The use of Tac/MMF combination has increased in recent years and it is now widely used in transplantation [10–12]. With regard to pharmacokinetics, in contrast to Tac, CsA interrupts
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