Switching from Calcineurin Inhibitor-based Regimens to a Belatacept-based Regimen in Renal Transplant Recipients

Abstract

SummaryBackground and objectives Prolonged use of calcineurin inhibitors (CNIs) in kidney transplant recipients is associated with renal and nonrenal toxicity and an increase in cardiovascular risk factors. Belatacept-based regimens may provide a treatment option for patients who switch from CNI-based maintenance immunosuppression.Design, setting, participants, & measurements This is a randomized, open-label Phase II trial in renal transplant patients with stable graft function and receiving a CNI-based regimen. Patients who were Ն6 months but Յ36 months after transplantation were randomized to either switch to belatacept or continue CNI treatment. All patients received background maintenance immunosuppression. The primary end point was the change in calculated GFR (cGFR) from baseline to month 12.Results Patients were randomized either to switch to belatacept (n ϭ 84) or to remain on a CNI-based regimen (n ϭ 89). At month 12, the mean (SD) change from baseline in cGFR was higher in the belatacept group versus the CNI group. Six patients in the belatacept group had acute rejection episodes, all within the first 6 months; all resolved with no allograft loss. By month 12, one patient in the CNI group died with a functioning graft, whereas no patients in the belatacept group had graft loss. The overall safety profile was similar between groups. ConclusionsThe study identifies a potentially safe and feasible method for switching stable renal transplant patients from a cyclosporine-or tacrolimus-based regimen to a belatacept-based regimen, which may allow improved renal function in patients currently treated with CNIs.

Renal Allograft Fibrosis: Biology and Therapeutic Targets

“…An almost identical observation has been made in the case of an everolimus-based regimen (245). Other calcineurin-inhibitor-sparing approaches involving, for example, belatacept, have been tested and also resulted in better preservation of GFR despite higher initial rejection rates (246,247). Whether the better preservation of GFR in the latter studies resulted from less fibrosis and/or hemodynamic effects such as lesser vasoconstriction, is currently unknown.…”

Conversion From Tacrolimus to Belatacept to Prevent the Progression of Chronic Kidney Disease in Pancreas Transplantation: Case Report of Two Patients

“…Based on the clinical course and biopsy findings, both cases clearly show that the poor renal function was due to TAC therapy. Belatacept has been studied extensively recently in kidney transplant patients (8)(9)(10)(11)(12). Treatment with belatacept is associated with better renal function, less CAN and an improved cardiovascular risk factor profile compared with cyclosporine.…”

Plasma exchange in small intestinal transplantation between ABO-incompatible individuals: A case report

“…Small intestinal transplantation under conditions of blood group incompatibility may stimulate a hyperacute and acute rejection reaction (7). If the titers of blood type antibodies are relatively high, a hyperacute rejection reaction may occur within minutes to hours after the transplantation.…”