title: Efficacy and Safety Outcomes of Extended Criteria Donor Kidneys by Subtype: Subgroup Analysis of BENEFIT-EXT at 7 Years After Transplant.
abstract: The phase III Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Immunosuppression Trial-Extended Criteria Donors Trial (BENEFIT-EXT) study compared more or less intensive belatacept-based immunosuppression with cyclosporine (CsA)-based immunosuppression in recipients of extended criteria donor kidneys. In this post hoc analysis, patient outcomes were assessed according to donor kidney subtype. In total, 68.9% of patients received an expanded criteria donor kidney (United Network for Organ Sharing definition), 10.1% received a donation after cardiac death kidney, and 21.0% received a kidney with an anticipated cold ischemic time ≥24 h. Over 7 years, time to death or graft loss was similar between belatacept- and CsA-based immunosuppression, regardless of donor kidney subtype. In all three donor kidney cohorts, estimated mean GFR increased over months 1-84 for belatacept-based treatment but declined for CsA-based treatment. The estimated differences in GFR significantly favored each belatacept-based regimen versus the CsA-based regimen in the three subgroups (p < 0.0001 for overall treatment effect). No differences in the safety profile of belatacept were observed by donor kidney subtype.
authors.affiliation: Recanti/Miller Transplant Institute, Mount Sinai Medical Center, New York, NY.
authors.forename: S
authors.initials: S
authors.lastname: Florman
authors.affiliation: Clinic for General Surgery, Visceral, Thoracic, Transplantation and Pediatric Surgery, University Hospital Schleswig-Holstein, Kiel, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Becker
authors.affiliation: Department of Nephrology, Medical College of Wisconsin, Milwaukee, WI.
authors.forename: B
authors.initials: B
authors.lastname: Bresnahan
authors.affiliation: Department of Nephrology and Dialysis, Hospital Central, San Luis Potosi, Mexico.
authors.forename: A
authors.initials: A
authors.lastname: Chevaile-Ramos
authors.affiliation: Renal Transplant Unit, Hospital Geral De Bonsucesso, Rio de Janeiro, Brazil.
authors.forename: D
authors.initials: D
authors.lastname: Carvalho
authors.affiliation: Department of General, Visceral and Transplantation Surgery, Medizinische Hochschule Hannover, Hannover, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Grannas
authors.affiliation: Univ. Klinik Fur Chirurgie, Medizinische Universitat Wien, Vienna, Austria.
authors.forename: F
authors.initials: F
authors.lastname: Muehlbacher
authors.affiliation: Department of Renal Medicine, University of Sydney Westmead Hospital, New South Wales, Australia.
authors.forename: P J
authors.initials: PJ
authors.lastname: O'Connell
authors.affiliation: Bristol-Myers Squib, Princeton, NJ.
authors.forename: H U
authors.initials: HU
authors.lastname: Meier-Kriesche
authors.affiliation: Emory Transplant Center and Department of Surgery, Emory University Transplant Center, Atlanta, GA.
authors.forename: C P
authors.initials: CP
authors.lastname: Larsen
mesh_terms: D000069594:Abatacept / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000188:drug therapy*; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007676:Kidney Failure, Chronic / Q000601:surgery*; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012307:Risk Factors; D012449:Safety; D014019:Tissue Donors
chemical_list: D007166:Immunosuppressive Agents; D000069594:Abatacept
keywords: calcineurin inhibitor: cyclosporine A (CsA); clinical research/practice; donors and donation: deceased; donors and donation: donation after circulatory death (DCD); donors and donation: extended criteria; immunosuppressant; kidney transplantation/nephrology