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|
Ti- inflammation in unscarred and scarred
|Vascular intimal thickening||0.45||0.82||<0.0001||0.44||0.71||0.0067||0.3179|
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 February 25, 2021.
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