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Background  Chronic active antibody mediated rejection (c-aABMR) is a major cause of long-term kidney allograft loss. It is hypothesized that frequent sub-therapeutic exposure to immunosuppressive drugs, in particular tacrolimus (Tac), is a risk factor for the development of c-aABMR. The intra-patient variability (IPV) in Tac exposure may serve as a substitute biomarker for underexposure and/or non-adherence. In this study, the association between Tac IPV and the development of c-aABMR was investigated.    Methods  We retrospectively included 59 patients diagnosed with c-aABMR and compared them to 189 control patients matched for age, year of transplantation and type of kidney donor. The Tac IPV was calculated from pre-dose tacrolimus concentrations measured over a 3 year period preceding the diagnosis of c-aABMR. The mean Tac predose concentrations (C 0 ), Tac IPV, renal allograft function and graft survival were compared between the groups.    Results  Tac IPV was 24.4% for the cases  versus  23.6% for the controls (p = 0.47). The mean Tac C 0  was comparable for the cases (5.8 ng/mL) and control patients (6.1 ng/mL, p = 0.08). Only in the c-aABMR group a significant decline in both mean Tac C 0  and allograft function over the timespan of 3 years was observed (p = 0.03 and p<0.001). Additionally, in the group of c-aABMR patients a high IPV was associated with inferior graft survival (p = 0.03).    Conclusions  A high Tac IPV  per se  does not predispose to the development of c-aABMR but is associated with inferior graft survival once c-aABMR is diagnosed.

Tacrolimus intra-patient variability is not associated with chronic active antibody mediated rejection