Date: Sunday, June 12, 2016
Session Name: Concurrent Session: Kidney Transplant: CNI Minimization
Session Time: 2:30pm-4:00pm
Presentation Time: 3:42pm-3:54pm
Location: Room 311
Introduction. Recent clinical trials have shown that the combination of CNIs with Everolimus (EVE) allows CNIs minimization, which may positively impact on chronic nephrotoxicity. Aim of this pilot, prospective, randomized clinical trial was to evaluate the long term safety and efficacy of once-daily administration of a combination of CNIs and mTORi in KTx on maintenance therapy.
Methods. Ninety-six KTx were randomized to once-daily maintenance immunosuppressive regimen based on Tacrolimus + Mycophenolate Mofetil + Steroids (TAC+MMF, n=44), Tacrolimus + Everolimus + Steroids (TAC+EVE, n=34), Cyclosporine + Everolimus + Steroids (CSA+EVE, n=18). All patients received induction therapy with a combination of Thymoglobuline and Basiliximab. Median follow-up was 61 months (range 22-86).
Results. Randomization to CSA+EVE was prematurely terminated due to a higher rate of acute rejection during steroids withdrawal. Here we report the intention-to-treat analysis of TAC+EVE vs TAC+MMF at 6 months, 1y, 3 and 5 years. At 5 year follow-up no differences in patient and graft survival were found, but significantly better renal function, lower acute rejection rate and lower PCR-Cytomegalovirus infection were observed in the TAC+EVE vs TAC+MMF combination. Exposure to Tacrolimus blood levels was significantly lower in KTx receiving TAC+EVE compared to those receiving TAC+MMF. Data are detailed below.
|5 Year follow up||TAC + MMF||TAC + EVE||p|
|Patients Survival (%)||91||93||0.814|
|Graft Survival death-censored (%)||96||95||0.823|
|aMDRD (ml/min)||49 ± 17||66 ± 17||0.013|
|Acute Rejection (%)||11||3||0.029|
|Cytomegalovirus infection (PCR-CMV-DNA +, %)||70||38||0.004|
|Steroid free (%)||20||23||0.478|
|TACROLIMUS through blood levels (ng/ml)||5.7 ± 1.3||4.1 ± 0.9||0.001|
Conclusions. Our data support the safety of combining Tacrolimus and Everolimus in a once-daily maintenance therapy. As compared to the standard regimen of TAC+MMF, TAC+EVE is associated with better long-term renal function, lower incidence of acute rejection, lower CMV infection. Moreover, the lower Tacrolimus exposure used in the combination with Everolimus may decrease the long term CNI nephrotoxicity.
CITATION INFORMATION: Spagnoletti G, Salerno M, Bianchi V, Silvestrini N, Apponi F, Romagnoli J, Citterio F. Better Long-Term Renal Function with Lower Incidence of Acute Rejection and Lower CMV Infection in Renal Transplant Patients Treated with a Combination of Tacrolimus and Everolimus. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:Spagnoletti G, Salerno M, Bianchi V, Silvestrini N, Apponi F, Romagnoli J, Citterio F. Better Long-Term Renal Function with Lower Incidence of Acute Rejection and Lower CMV Infection in Renal Transplant Patients Treated with a Combination of Tacrolimus and Everolimus. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/better-long-term-renal-function-with-lower-incidence-of-acute-rejection-and-lower-cmv-infection-in-renal-transplant-patients-treated-with-a-combination-of-tacrolimus-and-everolimus/. Accessed August 8, 2020.
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