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Medical Science Monitor Basic Research

AmJCaseRep
MedSciTechnol

eISSN: 2329-0358

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Conversion from everolimus with low-exposure cyclosporine to everolimus with mycophenolate sodium maintenance therapy in kidney transplant recipients: A randomized, open-label multicenter study

Laetitia Albano, Eric Alamartine, Olivier Toupance, Bruno Moulin, Pierre Merville, Jean Philippe Rerolle, Rachel Tetaz, Marie-Christine Moal, Nassim Kamar, Christophe Legendre, Stéphane Quéré, Fabienne Di Giambattista, Arara Terpereau, Jacques Dantal

Ann Transplant 2012; 17(1): 58-67

DOI: 10.12659/AOT.882637


Background:    Data in kidney transplant recipients regarding elimination of calcineurin inhibitor (CNI) therapy from a de novo regimen based on low CNI exposure and an mTOR inhibitor are sparse, and restricted to CNI elimination within the first six months post-transplant.
    Material/Methods:    In a 12-month, randomized, multicenter, open-label study, kidney transplant patients who had received everolimus, low-exposure cyclosporine and corticosteroids from transplantation to month 12 (with proteinuria <1 g/24 h at month 12) were randomized to convert from cyclosporine to mycophenolate sodium 720 mg/day with increased everolimus exposure (6–10 ng/mL [CNI-free group], n=15) or continue unchanged (everolimus 3–8 ng/mL [CNI group], n=15).
    Results:    Median (range) baseline mGFR was 54 (21–87) mL/min and 37 (range 18–69) mL/min (p=0.053) in the CNI-free and CNI groups, respectively, compared to 56 (18–126) mL/min and 32 (12–63) mL/min at month 12 (p=0.007). The between-group difference in change in mGFR from baseline to month 12 post-conversion (the primary endpoint) was –14.4 mL/min (95% CI –29.3 to 0.6 mL/min, p=0.059 [least squares mean]). Changes in serum creatinine and estimated GFR to month 12 were significantly in favor of CNI-free patients. One CNI patient experienced biopsy-proven acute rejection. Study drug was discontinued due to adverse events in one CNI-free patient (7%) and three CNI-treated patients (20.0%).
    Conclusions:    Elimination of CNI from a de novo regimen of everolimus with low-exposure CNI at one year post-transplant maintained efficacy and led to a non-significant but clinically relevant improvement in renal function, although patients numbers were low (n=30). Findings from this small study require confirmation in a larger controlled trial.

This paper has been published under Creative Common Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) allowing to download articles and share them with others as long as they credit the authors and the publisher, but without permission to change them in any way or use them commercially.
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