Everolimus/Low Tacrolimus(TAC) Compared to MPA/RegularTAC for Renal Transplantation in the Elderly Recipient – Preliminary Analysis of the nEverOld Trial.
1Kidney Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, Sao Paulo, Brazil
2Geriatric Service, Hospital das Clínicas, University of São Paulo School of Medicine, Sao Paulo, Brazil.
Meeting: 2016 American Transplant Congress
Abstract number: 288
Keywords: Elderly patients, Immunosuppression, Kidney transplantation
Session Information
Session Name: Concurrent Session: Belatacept and Steroid Withdrawal in Kidney Transplantation
Session Type: Concurrent Session
Date: Monday, June 13, 2016
Session Time: 4:30pm-6:00pm
Presentation Time: 5:30pm-5:42pm
Location: Ballroom A
In the last decade, elderly patients (≥60y) have been more frequently listed for renal transplantation. From 2007 to 2014 the percentage of elderly renal transplant recipients increased from 11% to 21%, at our center. Elderly recipients are more prone to develop diabetes, Infection, cardio-vascular disease and cancer. The nEverOld trial is an ongoing, single center, prospective randomized trial, comparing conversion to low TAC/Everolimus (EVL) at 1st month with TAC/enteric coated – sodium mycophenolate (EC-MPS) in elderly renal transplant recipients (≥60y). All received induction therapy with ATG (single dose of 2mg/kg). Patients received oral valGCV prohylaxis up to 90 days that was withdrawn when EVL started. So far, 72 (80% of total) patients with a mean age of 65±4 (60-78) years, have been enrolled:39 in the lowTAC/EVL arm and 33 in the TAC/EM-MPS arm. Demographics and RTx features were very similar.TAC trough levels were lower (p<0.046) in the EVL arm at 3, 6 and 12 months, as per protocol. At the mean f-up of 425±352 days patient survival (76±8vs77±9%) death-censored graft survival (92±4vs90±7%) and eGFR(MDRD4) (48±19vs47±16ml/min/1.73m2) did not differ for EVL and MPS arm, respectively. 6/10 patients died before conversion In the EVL arm and 4/6 (before day 30), in the MPS arm. 50% due to infection. Although not statistically significant, there were 2 cancers, 2 BK nephropathy and 3 CMV disease in group MPA but only 1 CMV and less patients re-admitted to the hospital in the EVL arm less.
EVL/Low TAC n=39 |
MPS/TAC n=33 |
|
Deaths (before conversion or Day 30) | 10 (6) | 6 (4) |
Graft loss | 3 all before convertion to EVL (2 arterial thrombosis, 1 never functioning graft) |
2 (2 BKV nephopathy) |
IS change | 3 (2 proteinuria, 1 mTORi pneumopathy) |
4 (2 diarrhea, 2 BKV nephropathy) |
Acute Rejection | 9 (23%) | 6 (18%) |
Cancer | 0 | 2 (1 GI tract, 1 lymphoproliferative) |
BK nephropathy | 0 | 2 |
CMV disease | 1 | 3 |
DM pre/post tx | 14/2 | 19/3 |
Number of pts without hospitalization | 21 (54%) | 14 (42%) |
These data show that, so far, the EVL arm has the same efficacy but seems to have a better safety profile in elderly recipients.
CITATION INFORMATION: David-Neto E, Agena F, Ramos F, Triboni A, Altona M, Coelho V, Galante N, Lemos F. Everolimus/Low Tacrolimus(TAC) Compared to MPA/RegularTAC for Renal Transplantation in the Elderly Recipient – Preliminary Analysis of the nEverOld Trial. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:
David-Neto E, Agena F, Ramos F, Triboni A, Altona M, Coelho V, Galante N, Lemos F. Everolimus/Low Tacrolimus(TAC) Compared to MPA/RegularTAC for Renal Transplantation in the Elderly Recipient – Preliminary Analysis of the nEverOld Trial. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/everolimuslow-tacrolimustac-compared-to-mparegulartac-for-renal-transplantation-in-the-elderly-recipient-preliminary-analysis-of-the-neverold-trial/. Accessed September 7, 2024.« Back to 2016 American Transplant Congress