Comparative pharmacokinetic study of two mycophenolate mofetil formulations in stable kidney transplant recipients

Gere Sunder-Plassmann, Petra Reinke, Thomas Rath, Andrzej Wiecek, Michal Nowicki, Richard Moore, Jens Lutz, Martina Gaggl, Marek Ferkl, Gere Sunder-Plassmann, Petra Reinke, Thomas Rath, Andrzej Wiecek, Michal Nowicki, Richard Moore, Jens Lutz, Martina Gaggl, Marek Ferkl

Abstract

We compared steady-state pharmacokinetics of mycophenolate mofetil (MMF) - Myfenax(®) (Teva) and CellCept(®) (Roche) - in stable kidney transplant recipients (KTRs). This was an international, multi-centre, randomized, open-label, two-treatment, two-sequence crossover study with a 3-month follow-up. We included KTRs at least 12 months post-transplantation with stable renal graft function for at least 3 months. The maintenance treatment consisted of MMF in combination with tacrolimus with or without steroids. At the end of the two treatment periods, 6-h or 12-h PK studies of mycophenolic acid (MPA) were performed. A total of 43 patients (mean age: 50.7 ± 13.5 years; 19 females, 24 males) were randomized. Estimates of test to reference ratios (90% CIs) were 0.959 (0.899; 1.023) h*μg/ml for AUC((0-tau)) and 0.873 (0.787; 0.968) μg/ml for C(max). Estimates for AUC((0-6h)) were 0.923 (0.865; 0.984) h*μg/ml and 0.985 (0.877; 1.106) μg/ml for C(min). Thus, AUC((0-tau)), AUC((0-6h)), and C(min) of MPA were within the predefined margins. C(max) was somewhat outside of these margins in this set of patients. The numbers and types of adverse events were not different between the two treatments. The steady-state pharmacokinetics of MPA as well as adverse events are comparable for Myfenax(®) and CellCept(®) in tacrolimus-treated stable KTRs.

Trial registration: ClinicalTrials.gov NCT00991510.

© 2012 The Authors. Transplant International © 2012 European Society for Organ Transplantation.

Figures

Figure 1
Figure 1
Trial profile.
Figure 2
Figure 2
Plasma concentration time profile of MPA.

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