Date: Saturday, June 11, 2016
Session Time: 5:30pm-7:30pm
Presentation Time: 5:30pm-7:30pm
Location: Halls C&D
Previous studies have implicated the development of arteriolar hyalinosis (AH) following kidney transplantation to chronic calcineurin inhibitor nephrotoxicity. Here, we examined the association between tacrolimus (TAC) exposure and the presence of AH in transplant protocol biopsies.
In this 12 month, multicenter, open-label, non-inferiority study, renal transplant recipients (N=613) were randomized (1:1) to everolimus+low-dose TAC (EVR+LTAC) or mycophenolate mofetil+standard-dose TAC (MMF+STAC). The EVR+LTAC group received EVR to maintain a trough level of 3–8 ng/mL with LTAC (C0h 0–2 Months(M): 4–7 ng/mL, 2–6M: 3–6 ng/mL, 6–12M: 2–5 ng/mL. The MMF+STAC group received 2 g/day of MMF with STAC (C0h 0–2M: 8–12 ng/mL, 2–6M: 7–10 ng/mL, 6–12M: 5–8 ng/mL). The 6 month area under TAC and EVR trough levels curve (AUC) were calculated and the presence and severity of AH in central protocol biopsies at baseline and 6 months post-transplant were examined using Banff scores.
At baseline, 39% of MMF+STAC patients and 33% of EVR+LTAC patients exhibited AH. There was no change in AH prevalence, or in the mean AH score, to 6 months in either group (Table 1). AH scores were not correlated with TAC exposure and were similar in patients with upper and lower AUC levels for either group at 6 months (Table 2).
TAC treatment was not associated with AH in renal transplant patients 6 months post-transplant. Longer term data is needed to examine this conclusion beyond 6 months.
|Table 1||Baseline vs. 6 Month MMF+STAC (n=112)||Baseline vs. 6 Month EVR+LTAC (n=104)|
|Baseline||6 Month||P-Value||Baseline||6 Month||P-Value|
|AH prevalence, n (%)||44 (39)||31 (28)||0.0890||34 (33)||28 (27)||0.4486|
|AH score||0.45 (0.67)||0.31 (0.60)||0.0518||0.37 (0.64)||0.33 (0.61)||0.5219|
|Table 2||6 month AUC comparison MMF+STAC and EVR+LTAC combined||6 Month AUC comparison EVR+LTAC|
|Low TAC AUC (n=92) Mean (SD)||Upper TAC AUC (n=92) Mean (SD)||P-value||Low EVR AUC (n=43) Mean (SD)||Upper EVR AUC (n=43) Mean (SD)||P-value|
|AUC||925.3 (128.72)||1816.1 (261.41)||<0.0001||653 (115)||1222 (160)||<0.0001|
|AH score||0.30 (0.56)||0.36 (0.59)||0.4835||0.40 (0.57)||0.38 (0.69)||0.9324|
CITATION INFORMATION: Yilmaz S, Shaffer D, Qazi Y, Shihab F, McCague K, Patel D, Vincenti F. Arteriolar Hyalinosis on Renal Transplant Protocol Biopsies Is Not Associated with Tacrolimus Exposure. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:Yilmaz S, Shaffer D, Qazi Y, Shihab F, McCague K, Patel D, Vincenti F. Arteriolar Hyalinosis on Renal Transplant Protocol Biopsies Is Not Associated with Tacrolimus Exposure. [abstract]. Am J Transplant. 2016; 16 (suppl 3). http://atcmeetingabstracts.com/abstract/arteriolar-hyalinosis-on-renal-transplant-protocol-biopsies-is-not-associated-with-tacrolimus-exposure/. Accessed December 17, 2017.
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