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

Session Name: Concurrent Session: Kidney Transplant: CNI Minimization

Session Type: Concurrent Session

Date: Sunday, June 12, 2016

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

Presentation Time: 2:30pm-2:42pm

Location: Room 311

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).

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 July 3, 2025.

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