Every 2‐month belatacept maintenance therapy in kidney transplant recipients greater than 1‐year posttransplant: A randomized, noninferiority trial

Belatacept results in improved kidney transplant outcomes, but utilization has been limited by logistical barriers related to monthly (q1m) intravenous infusions. Every 2‐month (q2m) belatacept has potential to increase utilization, therefore we conducted a randomized noninferiority trial in low immunologic risk renal transplant recipients greater than 1‐year posttransplant. Patients on belatacept were randomly assigned to q1m or q2m therapy. The primary objective was a noninferiority comparison of renal function (eGFR) at 12 months with a noninferiority margin (NIM) of 6.0 ml/min/1.73 m2. One hundred and sixty‐six participants were randomized to q1m (n = 82) or q2m (n = 84) belatacept, 163 patients received treatment, and 76 q1m and 77 q2m subjects completed the 12‐month study period. Every 2‐month belatacept was noninferior to q1m, as the difference in mean eGFR adjusted for baseline renal function did not exceed the NIM. Two‐month dosing was safe and well tolerated, with no patient deaths or graft losses. Four rejection episodes and three cases of donor‐specific antibodies (DSAs) occurred among q2m subjects; however, only one rejection and one instance of DSA were observed in subjects adherent to the study protocol. Every 2‐month belatacept therapy may facilitate long‐term utilization of costimulation blockade, but future multicenter studies with long‐term follow‐up will further elucidate immunologic risk. (ClinicalTrials.gov NCT02560558). This single‐center trial randomized stable kidney transplant recipients more than one year posttransplant to every 2 months versus standard monthly belatacept dosing shows noninferiority, as determined by renal function 12 months after randomization.