Conversion from tacrolimus-based to everolimus-based immune-suppressive therapy 3 months after living-donor kidney trans-plantation: A randomized-controlled clinical trial

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R. Bouamar, N.M. Shuker, J.A.J. Osinga, M.C. Clahsen-van Groningen, J. Damman, C.C. Baan, J. van de Wetering, A.T. Rowshani, J. Kal-van Gestel, W. Weimar, T. van Gelder, D.A. Hesselink

Chair(s): dr. M.A.C.J. Gelens

Thursday 9 march 2017

12:30 - 12:45h

Categories: Poster - Klinisch

Parallel session: Postersessie - Klinisch 4

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While conversion from ciclosporin to everolimus is well documented, conversion from tacrolimus has been poorly studied.

In this randomized-controlled trial the safety and tolerability of switching from tacrolimus to everolimus with glucocorticoid withdrawal after living-donor kidney transplantation was studied. 194 patients were planned to be randomized 1:1 to either continue tacrolimus or to convert to everolimus at  month 3 after transplantation.

At randomization, all patients received tacrolimus, mycophenolate mofetil and prednisolone. Everolimus was started in a dose of 1.5 mg bid, aiming for predose concentrations of 4-7 ng/mL. Prednisolone was gradually withdrawn in both groups. The trial was stopped prematurely after the inclusion of 60 patients. The interim analysis showed an unacceptably high rejection rate in the everolimus group as compared to the control group: 30.0% vs. 6.7% (95%-CI: 0.047-0.420; p = 0.045). An additional 8 patients stopped everolimus because of toxicity. At the end of follow-up (month 12) only 12 (40%) patients assigned to everolimus were still on study drug. 

Conversion from tacrolimus to everolimus-based immunosuppression with withdrawal of prednisolone 3 months after kidney transplantation results in an unacceptably high risk of acute rejection and causes considerable toxicity. Based on our findings, such a switch strategy cannot be recommended.