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2018 ; 4
(7
): e369
Nephropedia Template TP
gab.com Text
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English Wikipedia
Nuclear Factor of Activated T Cell-regulated Cytokine Gene Expression for
Adjustment of Tacrolimus in Kidney Transplant Recipients: A Randomized Controlled
Pilot Trial
#MMPMID30046659
Webber AB
; Tatapudi V
; Maw TT
; Peralta C
; Leung JCY
; Vincenti F
Transplant Direct
2018[Jul]; 4
(7
): e369
PMID30046659
show ga
BACKGROUND: The aim of this pilot study was to assess the feasibility of a
pharmacodynamics assay that measures Nuclear Factor of Activated T Cell-dependent
cytokines expressed as % mean residual expression (MRE) to adjust tacrolimus
(tac) dose (intervention [INT] arm) in comparison with the standard of care of
tac trough levels (control [CTL] arm). METHODS: We conducted a single-center
randomized controlled trial involving 40 stable kidney transplant recipients over
1 year. In the INT arm, the dose of tac was reduced by 15% if the MRE was less
than 20% and was increased by 15% if the MRE was greater than 60%. Controls were
adjusted based on tac trough levels. RESULTS: There was a median of 2 tac dose
changes per arm. Ten subjects had 1 or more infections in the INT arm and 6
subjects had 1 or more infection in the CTL arm. Rates for hospitalizations,
rejections, malignancies and death were similar in both arms. In subjects whose
tac dose was not adjusted in the first 6 months, those with infections had a
lower MRE at enrollment compared with those without infections (P = 0.049). This
was not true for tac trough levels (P = 0.80). There was no correlation between
MRE and rejection. CONCLUSIONS: Our study suggests that adjusting tac based on
this pharmacodynamics assay is feasible. Quantitative analysis of nuclear factor
of activated T-regulated gene expression may serve as a reliable assay to lower
tac dosing. Further studies with larger populations are needed.