Reduction of Extended-Release Tacrolimus Dose in Low-Immunological-Risk Kidney Transplant Recipients Increases Risk of Rejection and Appearance of Donor-Specific Antibodies: A Randomized Study

• DOI: 10.1111/ajt.14109
• Publication Date: 2016-11-10T01:48:58Z
• Authors: P. Gatault; N. Kamar; M. Büchler; C. Colosio; D. Bertrand; A. Durrbach; L. Albano; J. Rivalan; Y. Le Meur; M. Essig; N. Bouvier; C. Legendre; B. Moulin; A.-E. Heng; P.-F. Weestel; J. Sayegh; B. Charpentier; L. Rostaing; E. Thervet; Y. Lebranchu
• Keywords: Donor-Specific Antibodies; Graft rejection

The aim of this study (ClinicalTrials.gov, NCT01744470) was to determine the efficacy and safety two different doses extended-release tacrolimus (TacER) in kidney transplant recipients (KTRs) between 4 12 mo after transplantation. Stable steroid-free KTRs were randomized (1:1) mo: Group A had a 50% reduction TacER dose with targeted trough level (C0) >3 μg/L; group B no change (TacER C0 7–12 μg/L). primary outcome estimated GFR at 1 year. Of 300 patients, intent-to-treat analysis included 186 patients (group A, n = 87; B, 99). lower than 6 (4.1 ± 2.7 vs. 6.7 3.9 μg/L, p < 0.0001) (5.6 2.0 7.4 2.1 0.0001). Estimated similar both groups 56.0 17.5 mL/min per 1.73 m²; 22.1 m²). More rejection episodes occurred (11 3; 0.016). At year, subclinical inflammation more frequently (inflammation score [i] >0: 21.4% 8.8%, 0.047; tubulitis [t] 19.6% 8.7%, 0.076; i + t: 1.14 1.21 0.72 1.01, 0.038). Anti-HLA donor-specific antibodies appeared only (6 0 0.008). should be maintained >7 μg/L during first year transplantation low-immunological-risk, receiving moderate mycophenolic acid.