A randomized exploratory trial of steroid avoidance in renal transplant patients treated with everolimus and low-dose cyclosporine

Montagnino, Giuseppe; Sandrini, Silvio; Iorio, B; Schena, Francesco Paolo; Carmellini, Mario; Rigotti, Paolo; Cossu, Maria Vittoria; Altieri, Paolo; Salvadori, Maurizio; Stefoni, Sergio; Corbetta, G.; Ponticelli, Claudio

doi:10.1093/ndt/gfm621

Cited by 40 publications

(37 citation statements)

References 27 publications

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“…The overall incidence of lymphocele was lower than 20%, an incidence that is comparable with that observed in transplant patients not given mammalian target of rapamycin inhibitors (14,23) and with the 7.2% to 18.6% reported in former EVL trials (2,4,5,24,25). There was a trend for more frequent and more serious lymphocele in group B.…”

Section: Discussionsupporting

confidence: 70%

Everolimus With Very Low-Exposure Cyclosporine A in De Novo Kidney Transplantation: A Multicenter, Randomized, Controlled Trial

et al. 2009

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Section: Discussionsupporting

confidence: 70%

Everolimus With Very Low-Exposure Cyclosporine A in De Novo Kidney Transplantation: A Multicenter, Randomized, Controlled Trial

et al. 2009

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“…Similarly, previous studies have also reported no difference in renal function for those patients on RDP versus maintenance steroids (21)(22)(23). RDP-treated recipients do, however, have an increased rate of AR but not an increase in AR episodes requiring antibody treatment (12,14,16).…”

Section: Discussionmentioning

confidence: 63%

Ten-Year Outcome after Rapid Discontinuation of Prednisone in Adult Primary Kidney Transplantation

Rizzari¹,

Suszynski²,

Gillingham³

et al. 2012

Clinical Journal of the American Society of Nephrology

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SummaryBackground and objectives Rapid discontinuation of prednisone after kidney transplantation potentially allows for minimization of steroid-related side effects. Although intermediate-term data with rapid discontinuation of prednisone have been promising, concern still exists regarding long-term outcomes. The 10-year experience is reported herein.Design, setting, participants, & measurements Between October 1, 1999 and December 31, 2010, 1241 adult primary kidney transplants (791 living donor and 450 deceased donor) were performed using a protocol in which prednisone is discontinued after postoperative day 5. The 10-year actuarial recipient and graft survival rates and prednisone-related side effects were studied.Results Ten-year actuarial patient survival was 71% for living donor transplants and 62% for deceased donor transplants; 10-year graft survival was 61% for living donor transplants and 51% for deceased donor transplants, and was comparable to 10-year Scientific Registry of Transplant Recipients national data. Ten-year deathcensored graft survival was 79% for living donor transplants and 80% for deceased donor transplants. Ten-year acute rejection rates were 25% for deceased donor transplants and 31% for living donor transplants; 10-year chronic rejection (interstitial fibrosis/tubular atrophy) rates were 39% for deceased donor transplants and 47% for living donor transplants. For nondiabetic recipients of living donor or deceased donor allografts, the incidence of new-onset diabetes was significantly lower than in historical controls on prednisone (P,0.001). We also found significantly reduced rates of cataracts, avascular necrosis, and cytomegalovirus infection in some subgroups.Conclusions Prednisone-related side effects can be minimized in a protocol incorporating rapid discontinuation of prednisone for maintenance immunosuppression. Ten-year patient and graft outcomes remain acceptable.

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“…Within the duration of published trials, this regimen has shown a small numerical benefit for renal function versus a standard CNI-based regimen that only reached significance when very low CsA exposure was achieved [19]. It should be noted that randomized trials of early steroid withdrawal (7-14 days post-transplant) in patients receiving a de novo regimen of everolimus with reduced CNI have shown an increased risk of acute rejection [27,28].…”

Section: De Novo Everolimus With Reduced-exposure Cnimentioning

confidence: 99%

Everolimus immunosuppression in kidney transplantation: What is the optimal strategy?

Witzke

Sommerer

Arns

2016

Transplantation Reviews

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A randomized exploratory trial of steroid avoidance in renal transplant patients treated with everolimus and low-dose cyclosporine

Cited by 40 publications

References 27 publications

Everolimus With Very Low-Exposure Cyclosporine A in De Novo Kidney Transplantation: A Multicenter, Randomized, Controlled Trial

Everolimus With Very Low-Exposure Cyclosporine A in De Novo Kidney Transplantation: A Multicenter, Randomized, Controlled Trial

Ten-Year Outcome after Rapid Discontinuation of Prednisone in Adult Primary Kidney Transplantation

Everolimus immunosuppression in kidney transplantation: What is the optimal strategy?

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