Everold: A Multicenter Randomized Study for the Use of Everolimus in “Old-for-Old” Renal Transplantation.

Meur, Yann Le; Büchler, Markus W.; Mousson, C.; Moal, Marie-Christine; Albano, L.; Merville, Pierre; Caillard, Sophie; Étienne, Isabelle; Hazzan, Marc; Anglicheau, Dany; Rérolle, Jean Philippe; Heng, Anne Elisabeth; Thierry, Antoine; Vignaud, C.; Toupance, Olivier; Châtelet, Valérie; Mazouz, Hakim; Mourad, Georges; Kamar, Nassim

doi:10.1097/00007890-201407151-00350

Cited by 5 publications

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“…Yet, a retrospective analysis of 581 patients in different clinical trials, comparing SRL or EVR or AZA or MMF combinations in ICN, showed no difference in the incidence of AR, graft loss, and death . Therefore, it is plausible to speculate that the interaction of several risk factors including donor characteristics, prolonged cold ischemia time, ischemia‐reperfusion injury, and pre‐existing kidney histological lesions increased the susceptibility to the potential nephrotoxic effects of the r‐ATG/EVR regime .…”

Section: Discussionmentioning

confidence: 99%

Prospective randomized study comparing everolimus and mycophenolate sodium inde novokidney transplant recipients from expanded criteria deceased donor

et al. 2019

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Summary The optimal immunosuppressive regimen for recipients of expanded criteria donor (ECD) kidneys has not been identified. In this single‐center study, 171 recipients of ECD kidney transplants were randomized to receive antithymocyte globulin induction, and delayed introduction of reduced dose tacrolimus, prednisone and everolimus (r‐ATG/EVR, n = 88), or mycophenolate (r‐ATG/MPS, n = 83). No cytomegalovirus (CMV) pharmacological prophylaxis was used. The primary endpoint was the incidence of CMV infection/disease at 12 months. Secondary endpoints included treatment failure [first biopsy‐proven acute rejection (BPAR), graft loss, or death] and safety. Patients treated with EVR showed a 89% risk reduction (13.6 vs. 71.6%; HR 0.11, 95% CI 0.06–0.220, P < 0.001) in the incidence of first CMV infection/disease. Incidences of BPAR (16% vs. 5%, P = 0.021), graft loss (11% vs. 1%, P = 0.008), death (10% vs. 1%, P = 0.013), and treatment discontinuation (40% vs. 28%, P = 0.12) were higher in the r‐ATG/EVR, leading to premature study termination. Mean glomerular filtration rate was lower in r‐ATG/EVR (31.8 ± 18.8 vs. 42.6 ± 14.9, P < 0.001). In recipients of ECD kidney transplants receiving no CMV pharmacological prophylaxis, the use of everolimus was associated with higher treatment failure compared with mycophenolate despite the significant reduction in the incidence of CMV infection/disease (ClinicalTrials.gov.NCT01895049).

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Section: Discussionmentioning

confidence: 99%

Prospective randomized study comparing everolimus and mycophenolate sodium inde novokidney transplant recipients from expanded criteria deceased donor

et al. 2019

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“…Presenting with a high rate of co-morbidities on one hand, and decreased innate and adaptive immunity on the other [3], immunosuppressive regimens tailored specifically for ESP transplant recipients have long been the subject of debate [4]. However, the number of randomized studies investigating immunosuppressive regimens in elderly patients is remarkably small [4–8]. The protocols of many clinical trials exclude elderly recipients, a practice that has been repeatedly criticized by the Food and Drug Administration (FDA) [9].…”

Section: Introductionmentioning

confidence: 99%

Everolimus in de novo kidney transplant recipients participating in the Eurotransplant senior program: Results of a prospective randomized multicenter study (SENATOR)

Brakemeier

Arns²,

Lehner

et al. 2019

PLoS ONE

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Early conversion to everolimus was assessed in kidney transplant recipients participating in the Eurotransplant Senior Program (ESP), a population in whom data are lacking. The SENATOR multicenter study enrolled 207 kidney transplant recipients undergoing steroid withdrawal at week 2 post-transplant (ClinicalTrials.gov [NCT00956293]). At week 7, patients were randomized (1:2 ratio) to continue the previous calcineurin inhibitor (CNI)-based regimen with mycophenolic acid (MPA) and cyclosporine or switch to a CNI-free regimen with MPA, everolimus (5–10 ng/mL) and basiliximab at weeks 7 and 12, then followed for 18 weeks to month 6 post-transplant. The primary endpoint was estimated GFR (eGFR). At week 7, 77/207 (37.2%) patients were randomized (53 everolimus, 24 control). At month 6, eGFR was comparable: 36.5±10.8ml/min with everolimus versus 42.0±13.0ml/min in the control group (p = 0.784). Discontinuation due to adverse events occurred in 27.8% of everolimus-treated patients and 0.0% of control patients (p = 0005). Efficacy profiles showed no difference. In conclusion, eGFR, safety and efficacy outcomes at month 6 post-transplant showed no difference between groups. The everolimus group experienced a higher rate of discontinuation due to adverse events. However, the high rate of non-randomization is highly relevant, indicating this to be a somewhat unstable patient population regardless of treatment.

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Target of rapamycin inhibitors (TOR-I; sirolimus and everolimus) for primary immunosuppression in kidney transplant recipients

Hahn

Hodson

Hamiwka

et al. 2019

Cochrane Database of Systematic Reviews

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Everold: A Multicenter Randomized Study for the Use of Everolimus in “Old-for-Old” Renal Transplantation.

Cited by 5 publications

References 0 publications

Prospective randomized study comparing everolimus and mycophenolate sodium inde novokidney transplant recipients from expanded criteria deceased donor

Prospective randomized study comparing everolimus and mycophenolate sodium inde novokidney transplant recipients from expanded criteria deceased donor

Everolimus in de novo kidney transplant recipients participating in the Eurotransplant senior program: Results of a prospective randomized multicenter study (SENATOR)

Target of rapamycin inhibitors (TOR-I; sirolimus and everolimus) for primary immunosuppression in kidney transplant recipients

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