Efficacy and Safety Outcomes of Extended Criteria Donor Kidneys by Subtype: Subgroup Analysis of BENEFIT‐EXT at 7 Years After Transplant |
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| Authors: | S Florman T Becker B Bresnahan A Chevaile‐Ramos D Carvalho G Grannas F Muehlbacher P J O'Connell H U Meier‐Kriesche C P Larsen |
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| Institution: | 1. Recanti/Miller Transplant Institute, Mount Sinai Medical Center, New York, NY;2. Clinic for General Surgery, Visceral, Thoracic, Transplantation and Pediatric Surgery, University Hospital Schleswig‐Holstein, Kiel, Germany;3. Department of Nephrology, Medical College of Wisconsin, Milwaukee, WI;4. Department of Nephrology and Dialysis, Hospital Central, San Luis Potosi, Mexico;5. Renal Transplant Unit, Hospital Geral De Bonsucesso, Rio de Janeiro, Brazil;6. Department of General, Visceral and Transplantation Surgery, Medizinische Hochschule Hannover, Hannover, Germany;7. Univ. Klinik Fur Chirurgie, Medizinische Universitat Wien, Vienna, Austria;8. Department of Renal Medicine, University of Sydney Westmead Hospital, New South Wales, Australia;9. Bristol‐Myers Squib, Princeton, NJ;10. Emory Transplant Center and Department of Surgery, Emory University Transplant Center, Atlanta, GA |
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| 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. |
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| Keywords: | clinical research/practice kidney transplantation/nephrology donors and donation: deceased donors and donation: extended criteria donors and donation: donation after circulatory death (DCD) immunosuppressant calcineurin inhibitor: cyclosporine A (CsA) |
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