A Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study)

A Phase III Study of Belatacept Versus Cyclosporine in Kidney Transplants from Extended Criteria Donors (BENEFIT-EXT Study)

Author Durrbach, A. Google Scholar
Pestana, Jose Osmar Medina Autor UNIFESP Google Scholar
Pearson, T. Google Scholar
Vincenti, F. Google Scholar
Garcia, V. D. Google Scholar
Campistol, J. Google Scholar
del Carmen Rial, M. Google Scholar
Florman, S. Google Scholar
Block, A. Google Scholar
Di Russo, G. Google Scholar
Xing, J. Google Scholar
Garg, P. Google Scholar
Grinyo, J. Google Scholar
Institution Univ Paris 11
Universidade Federal de São Paulo (UNIFESP)
Emory Univ
Univ Calif San Francisco
Complexo Hosp Santa Casa
Univ Barcelona
Inst Nefrol
Tulane Sch Med
Bristol Myers Squibb Co
Univ Hosp Bellvitge
Abstract Recipients of extended criteria donor (ECD) kidneys are at increased risk for graft dysfunction/loss, and may benefit from immunosuppression that avoids calcineurin inhibitor (CNI) nephrotoxicity. Belatacept, a selective costimulation blocker, may preserve renal function and improve long-term outcomes versus CNIs. BENEFIT-EXT (Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial-EXTended criteria donors) is a 3-year, Phase III study that assessed a more (MI) or less intensive (LI) regimen of belatacept versus cyclosporine in adult ECD kidney transplant recipients. the coprimary endpoints at 12 months were composite patient/graft survival and a composite renal impairment endpoint. Patient/graft survival with belatacept was similar to cyclosporine (86% MI, 89% LI, 85% cyclosporine) at 12 months. Fewer belatacept patients reached the composite renal impairment endpoint versus cyclosporine (71% MI, 77% LI, 85% cyclosporine; p = 0.002 MI vs. cyclosporine; p = 0.06 LI vs. cyclosporine). the mean measured glomerular filtration rate was 4-7 mL/min higher on belatacept versus cyclosporine (p = 0.008 MI vs. cyclosporine; p = 0.1039 LI vs. cyclosporine), and the overall cardiovascular/metabolic profile was better on belatacept versus cyclosporine. the incidence of acute rejection was similar across groups (18% MI; 18% LI; 14% cyclosporine). Overall rates of infection and malignancy were similar between groups; however, more cases of posttransplant lymphoproliferative disorder (PTLD) occurred in the CNS on belatacept. ECD kidney transplant recipients treated with belatacept-based immunosuppression achieved similar patient/graft survival, better renal function, had an increased incidence of PTLD, and exhibited improvement in the cardiovascular/metabolic risk profile versus cyclosporine-treated patients.
Keywords Belatacept
cyclosporine
extended criteria donor
kidney
renal function
Language English
Sponsor Bristol- Myers Squibb
Roche
Pfizer
Novartis
Astellas
Genzyme
Genentech
Date 2010-03-01
Published in American Journal of Transplantation. Malden: Wiley-Blackwell Publishing, Inc, v. 10, n. 3, p. 547-557, 2010.
ISSN 1600-6135 (Sherpa/Romeo, impact factor)
Publisher Wiley-Blackwell
Extent 547-557
Origin http://dx.doi.org/10.1111/j.1600-6143.2010.03016.x
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000274621200016
URI http://repositorio.unifesp.br/handle/11600/32295

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