Kidney transplantation remains limited by toxicities of calcineurin inhibitors (CNIs) and steroids. Belatacept is a less toxic CNI alternative delivered by monthly intravenous infusion, but its clinical use has been hampered by early, high grade acute rejections. We have recently reported that a regimen including a single intraoperative dose of alemtuzumab followed by monthly belatacept and daily sirolimus can prevent rejection of live donor kidney transplants in non-allosensitized recipients. The current study was conducted to determine whether this regimen could be more generally applied to allosensitized individuals and recipients of deceased donor or extended criteria donor (ECD) kidneys. Ten deceased donor recipients were prospectively consented to receive kidneys under this regimen. Three were allosensitized (peak PRA 86%), and one received an ECD kidney. All patients have enjoyed stable and excellent graft function with a mean serum creatinine of 1.31mg/dl at a mean follow-up of 56 weeks. All patients remain on protocol. One patient has been intolerant to sirolimus, requiring conversion to mycophenolate. In the prior live donor cohort of this trial, 6 of 20 patients were weaned to monotherapy belatacept with follow-up exceeding 3 years, and in the current trial, two patients in the current deceased donor cohort have initiated sirolimus weaning. We have added an additional 10 live donor transplant recipients, making the total experience with this regimen 40 patients (20 from previous cohort, 10 new deceased donor and 10 additional live donor). From this pilot experience we conclude that belatacept and sirolimus effectively prevent deceased donor kidney allograft rejection without CNIs or steroids when used following alemtuzumab induction. The capacity of this protocol to allow for once monthly immunosuppressive management in deceased donors is being actively tested. Prospective controlled trials of this regimen using broad inclusion criteria are warranted.

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