Everolimus with Low-Dose Tacrolimus vs. a Standard Immunosuppressive Regimen: Renal Histology at 6 Months in De Novo Renal Transplant Patients.
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
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 May 28, 2020.« Back to 2016 American Transplant Congress