Improvement in renal function in kidney transplant recipients switched from cyclosporine or tacrolimus to belatacept: 2-year results from the long-term extension of a phase II study.

Autor: Grinyo J; University Hospital of Bellvitge, Barcelona, Spain. jgrinyo@bellvitgehospital.cat, Alberu J, Contieri FL, Manfro RC, Mondragon G, Nainan G, Rial Mdel C, Steinberg S, Vincenti F, Dong Y, Thomas D, Kamar N
Jazyk: angličtina
Zdroj: Transplant international : official journal of the European Society for Organ Transplantation [Transpl Int] 2012 Oct; Vol. 25 (10), pp. 1059-64. Date of Electronic Publication: 2012 Jul 21.
DOI: 10.1111/j.1432-2277.2012.01535.x
Abstrakt: Kidney transplant recipients who switched from a calcineurin inhibitor (CNI) to belatacept demonstrated higher calculated glomerular filtration rates (cGFRs) at 1 year in a Phase II study. This report addresses whether improvement was sustained at 2 years in the long-term extension (LTE). Patients receiving cyclosporine or tacrolimus were randomized to switch to belatacept or continue CNI. Of 173 randomized patients, 162 completed the 12-month main study and entered the LTE. Two patients (n = 1 each group) had graft loss between Years 1-2. At Year 2, mean cGFR was 62.0 ml/min (belatacept) vs. 55.4 ml/min (CNI). The mean change in cGFR from baseline was +8.8 ml/min (belatacept) and +0.3 ml/min (CNI). Higher cGFR was observed in patients switched from either cyclosporine (+7.8 ml/min) or tacrolimus (+8.9 ml/min). The frequency of acute rejection in the LTE cohort was comparable between the belatacept and CNI groups by Year 2. All acute rejection episodes occurred during Year 1 in the belatacept patients and during Year 2 in the CNI group. There were more non-serious mucocutaneous fungal infections in the belatacept group. Switching to a belatacept-based regimen from a CNI-based regimen resulted in a continued trend toward improved renal function at 2 years after switching.
(© 2012 The Authors. Transplant International © 2012 European Society for Organ Transplantation.)
Databáze: MEDLINE
Externí odkaz: