Every 2‐month belatacept maintenance therapy in kidney transplant recipients greater than 1‐year posttransplant: A randomized, noninferiority trial
American Journal of Transplantation Mar 20, 2021
Badell IR, Parsons RF, Karadkhele G, et al. - Given that improved kidney transplant results have been achieved with belatacept, however, logistical barriers associated with monthly (q1m) intravenous infusions have limited the utilization, and a potential of every 2‐month (q2m) belatacept to increase utilization has been suggested, thus, researchers performed a randomized noninferiority trial in low immunologic risk renal transplant recipients greater than 1‐year after transplant. They randomized patients on belatacept to q1m or q2m therapy. A noninferiority comparison of kidney function (eGFR) at 12 months with a noninferiority margin (NIM) of 6.0 ml/min/1.73 m 2, was the primary goal. Findings revealed the noninferiority of every 2‐month belatacept to q1m, because the difference in mean eGFR adjusted for baseline kidney function did not exceed the NIM. Safety as well as good tolerability of two‐month dosing was evident, with no patient deaths or graft losses. Experts inferred that long‐term utilization of costimulation blockade may be facilitated by every 2‐month belatacept therapy.
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