Conversion from Calcineurin Inhibitor- to Belatacept-Based Maintenance Immunosuppression in Renal Transplant Recipients: A Randomized Phase 3b Trial.
In a randomized phase 3b trial, converting stable kidney transplant recipients from calcineurin inhibitor to belatacept-based maintenance immunosuppression yielded similar graft survival, improved renal function, and fewer de novo donor-specific antibodies, but a numerically higher rate of biopsy-proven acute rejection.
Background
Calcineurin inhibitors (CNIs) are the standard of care after kidney transplantation but are associated with nephrotoxicity and reduced long-term graft survival. Belatacept, a selective T cell costimulation blocker, is approved for rejection prophylaxis, and conversion from CNI to belatacept is a strategy to avoid CNI-related toxicity.
Study design
This phase 3b trial randomized 446 stable adult kidney transplant recipients, 6 to 60 months post-transplant on CNI-based immunosuppression, 1:1 to either switch to belatacept (n=223) or continue their established CNI (n=223). The primary endpoint was the percentage of patients surviving with a functioning graft at 24 months.
Key findings
Rates of survival with graft function at 24 months were 98% with belatacept and 97% with CNI (adjusted difference 0.8; 95.1% CI -2.1 to 3.7). Biopsy-proven acute rejection occurred in 8% of the belatacept group versus 4% of the CNI group, while de novo donor-specific antibodies developed in 1% versus 7%. The 24-month estimated GFR was higher with belatacept (55.5 versus 48.5 mL/min per 1.73 m2), and rates of serious adverse events and infections were similar between groups.
Clinical implications
Switching stable recipients from CNI- to belatacept-based immunosuppression was associated with similar death or graft loss, improved renal function, and a lower incidence of de novo donor-specific antibodies, offset by a numerically higher acute rejection rate. These findings support belatacept conversion as an option for CNI avoidance while underscoring the need for close monitoring for rejection after the switch.
Category
Transplant
Source
J Am Soc Nephrol
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