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Arteriolar Hyalinosis on Renal Transplant Protocol Biopsies Is Not Associated with Tacrolimus Exposure.

S. Yilmaz,1 D. Shaffer,2 Y. Qazi,3 F. Shihab,4 K. McCague,5 D. Patel,5 F. Vincenti.6

1University of Calgary, Calgary, AB, Canada
2Vanderbilt University, Nashville, TN
3University of Southern California, Los Angeles, CA
4University of Utah, Salt Lake City, UT
5Novartis Pharmaceuticals Corporation, East Hanover, NJ
6University of California San Francisco, San Francisco, CA.

Meeting: 2016 American Transplant Congress

Abstract number: A235

Keywords: Biopsy, Histology, Kidney transplantation

Session Information

Date: Saturday, June 11, 2016

Session Name: Poster Session A: Long Term Outcomes in Kidney Transplantation

Session Time: 5:30pm-7:30pm

 Presentation Time: 5:30pm-7:30pm

Location: Halls C&D

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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).

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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). https://atcmeetingabstracts.com/abstract/arteriolar-hyalinosis-on-renal-transplant-protocol-biopsies-is-not-associated-with-tacrolimus-exposure/. Accessed February 25, 2021.

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