Wednesday, November 9, 2016

Reduction of extended-release tacrolimus dose in low immunological risk kidney transplant recipients increases risk of rejection and appearance of DSA - a randomized study

 

by Philippe Gatault, Nassim Kamar, Matthias Büchler, Charlotte Colosio, Dominique Bertrand, Antoine Durrbach, Laeticia Albano, Joseph Rivalan, Yannick Le Meur, Marie Essig, Nicolas Bouvier, Christophe Legendre, Bruno Moulin, Anne-Elisabeth Heng, Pierre-François Weestel, Johnny Sayegh, Bernard Charpentier, Lionel Rostaing, Eric Thervet, Yvon Lebranchu

Abstract

The aim of this study (NCT01744470) was to determine the efficacy and safety of two different doses of extended-release tacrolimus (TacER) in kidney transplant recipients (KTR) between 4 and 12 months post-transplantation. Stable steroid-free KTR were randomized (1:1) after 4 months: Group A 50%-reduction in TacER dose with targeted TacERC0>3μg/L; Group B no change in TacER dose (TacERC0=7-12μg/L). The primary outcome was eGFR at 1 year. Of 300 patients, intent-to-treat analysis included 186 patients (Group A 87, Group B 99). TacERC0 were lower in Group A than in Group B at 6 (4.1±2.7 vs 6.7±3.9μg/L, p<0.0001) and 12 months (5.6±2.0 vs 7.4±2.1μg/L, p<0.0001). eGFR was similar in both groups at 12 months (Group A 56.0±17.5ml/min/1.73m², Group B 56.0±22.1ml/min/1.73m²). More rejection episodes occurred in Group A (Group A 11, Group B 3; p=0.016). At one year, sub-clinical inflammation was more frequent in Group A than in Group B (i>0: 21.4% vs. 8.8%, p=0.047; t>0: 19.6% vs. 8.7%, p=0.076, i+t: 1.14±1.21 vs 0.72±1.01, p=0.038). DSA appeared only in Group A (6 patients vs. 0, p=0.008). TacERC0 should be maintained above 7μg/L during the first year post-transplantation in low immunological risk steroid-free KTR receiving moderate dose of MPA.

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