The Effect of Everolimus and Tacrolimus Exposure Levels on Renal Histology Parameters 6 Months Post-Transplantation.

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

¹University of Calgary, Calgary, Canada
²Vanderbilt University, Nashville
³University of Southern California, Los Angeles
⁴Novartis Pharmaceuticals Corporation, East Hanover
⁵California Pacific Medical Center, San Francisco
⁶University of California San Francisco, San Francisco.

Meeting: 2016 American Transplant Congress

Abstract number: A245

Keywords: Biopsy, Histology, Kidney transplantation

Session Information

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

Session Type: Poster Session

Date: Saturday, June 11, 2016

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

Presentation Time: 5:30pm-7:30pm

Location: Halls C&D

We examined renal histology scores in patients with different exposure levels of everolimus (EVR) and tacrolimus (TAC) over 6 months.

Renal transplant patients (N=613) were randomized (1:1) to EVR+low-dose TAC (EVR+LTAC) or mycophenolate mofetil+standard-dose TAC (MMF+STAC). EVR+LTAC received EVR to maintain a trough 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. MMF+STAC 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). 6 month EVR exposure level in the EVR+LTAC group was assessed using area-under-curve (AUC) values and patients were ranked and divided into 3 groups (highest to lowest, n=43 in each group). Histological scores were compared between the high and low exposure groups. The same analysis was undertaken for TAC exposure level in the EVR+LTAC group.

Histological scores were lower for those with higher EVR levels but no such impact was seen with higher TAC levels (Table).

Higher EVR levels were more effective at limiting renal damage 6 months post transplantation.

Low vs. High EVR AUC mean (SD)

Low vs. High TAC AUC mean (SD)

Low High P-value Low High P-value

AUC 653 (115) 1222 (160) <0.0001 811 (86) 1341 (253) <0.0001

Mean trough (ng/mL) 3.76 (0.78) 6.01 (1.03) <0.0001 5.52 (0.91) 7.47 (1.47) <0.0001

T-Tubilitis 0.7 (1.1) 0.3 (0.8) 0.0719 0.4 (0.8) 0.5 (1.1) 0.6453

I-Interstitial Inflammation 0.6 (1.0) 0.3 (0.6) 0.1609 0.4 (0.8) 0.4 (0.7) 1.0000

Ti-inflammation in unscarred and scarred 1.1 (1.0) 0.6 (0.7) 0.0233 0.7 (0.8) 0.8 (0.9) 0.6657

Ci-Interstitial Fibrosis 0.9 (1.0) 0.4 (0.6) 0.0090 0.5 (0.8) 0.7 (0.9) 0.2697

Ct-Tubular atrophy 0.9 (0.9) 0.4 (0.6) 0.0023 0.6 (0.8) 0.7 (0.8) 0.4492

Cv-Vascular intimal thickening 1.0 (1.0) 0.6 (0.8) 0.0710 1.0 (0.9) 0.9 (1.0) 0.8201

T+I+Ti 2.4 (2.8) 1.3 (1.8) 0.0462 1.6 (2.1) 1.8 (2.5) 0.7294

Ci+Ct+Cv 2.8 (2.6) 1.4 (1.8) 0.0055 2.0 (2.0) 2.2 (2.3) 0.5484

T+I+Ti+Ci+Ct+Cv 5.2 (5.2) 2.8 (3.0) 0.0098 3.6 (3.9) 4.0 (4.4) 0.6148

CADI 4.0 (3.6) 2.5 (2.4) 0.0260 2.9 (2.9) 3.3 (3.0) 0.5826

CITATION INFORMATION: Yilmaz S, Shaffer D, Qazi Y, McCague K, Patel D, Peddi V, Vincenti F. The Effect of Everolimus and Tacrolimus Exposure Levels on Renal Histology Parameters 6 Months Post-Transplantation. Am J Transplant. 2016;16 (suppl 3).

To cite this abstract in AMA style:

Yilmaz S, Shaffer D, Qazi Y, McCague K, Patel D, Peddi V, Vincenti F. The Effect of Everolimus and Tacrolimus Exposure Levels on Renal Histology Parameters 6 Months Post-Transplantation. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/the-effect-of-everolimus-and-tacrolimus-exposure-levels-on-renal-histology-parameters-6-months-post-transplantation/. Accessed May 9, 2025.

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