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Everolimus with Low-Dose Tacrolimus vs. a Standard Immunosuppressive Regimen: Renal Histology at 6 Months in De Novo Renal Transplant Patients.

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

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

Meeting: 2016 American Transplant Congress

Abstract number: 34

Keywords: Biopsy, Histology, Kidney transplantation

Session Information

Date: Sunday, June 12, 2016

Session Name: Concurrent Session: Kidney Transplant: CNI Minimization

Session Time: 2:30pm-4:00pm

 Presentation Time: 2:30pm-2:42pm

Location: Room 311

Related Abstracts
  • The Effect of Everolimus and Tacrolimus Exposure Levels on Renal Histology Parameters 6 Months Post-Transplantation.
  • Arteriolar Hyalinosis on Renal Transplant Protocol Biopsies Is Not Associated with Tacrolimus Exposure.

Morphologic changes in transplant protocol biopsies provide early evidence of renal damage. This study examined the renal histology of de novo patients 6 months post renal transplantation in those receiving everolimus (EVR) with low-dose tacrolimus (TAC) vs. a standard immunosuppressive regimen.

In this 12 month, multicenter, open-label, non-inferiority study, renal transplant recipients (N=613) were randomized (1:1) to either EVR+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). Central protocol biopsies at baseline and 6 months post-transplant were compared using Banff scores and the chronic allograft damage index (CADI).

From a similar baseline level, both EVR+LTAC (n=104) and MMF+STAC (n=112) groups experienced significant increases in renal histology scores to 6 months. There were no significant between group differences in the Banff scores (acute and chronic) or CADI at 6 months (Table 1).

EVR+LTAC is as effective as standard care in limiting acute and chronic renal damage 6 months post transplantation.

 Table 1. EVR+LTac                Baseline vs. 6 months MMF+STac               Baseline vs. 6 months 

EVR+LTac vs. MMF+STac at 6 months 

  Baseline mean 6 month mean P-value Baseline mean 6 month mean  P-value   P-value
Tubulitis 0.00 0.43 <0.0001  0.00  0.48  <0.0001  0.7134
Interstitial inflammation 0.02 0.39 <0.0001  0.02  0.29  <0.0001  0.2727

Ti- inflammation in unscarred and scarred 

0.07 0.75 <0.0001  0.12  0.66  <0.0001  0.3311
Interstitial fibrosis  0.10 0.51 <0.0001  0.16  0.39  0.0005  0.1458
Tubular atrophy  0.12 0.59 <0.0001  0.18  0.51  <0.0001  0.3397
Vascular intimal thickening  0.45 0.82 <0.0001  0.44  0.71  0.0067  0.3179
CADI 1.27 2.90 <0.0001  1.41  2.41  <0.0001  0.0905

CITATION INFORMATION: Yilmaz S, Shaffer D, Shihab F, McCague K, Patel D, Qazi Y, Vincenti F. Everolimus with Low-Dose Tacrolimus vs. a Standard Immunosuppressive Regimen: Renal Histology at 6 Months in De Novo Renal Transplant Patients. Am J Transplant. 2016;16 (suppl 3).

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To cite this abstract in AMA style:

Yilmaz S, Shaffer D, Shihab F, McCague K, Patel D, Qazi Y, Vincenti F. Everolimus with Low-Dose Tacrolimus vs. a Standard Immunosuppressive Regimen: Renal Histology at 6 Months in De Novo Renal Transplant Patients. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/everolimus-with-low-dose-tacrolimus-vs-a-standard-immunosuppressive-regimen-renal-histology-at-6-months-in-de-novo-renal-transplant-patients/. Accessed February 25, 2021.

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