Open AccessImprovement 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
Author(s) -
Grinyo Josep,
Alberu Josefina,
Contieri Fabiana L. C.,
Manfro Roberto C.,
Mondragon Guillermo,
Nainan Georgy,
Rial Maria del C.,
Steinberg Steven,
Vincenti Flavio,
Dong Yuping,
Thomas Dolca,
Kamar Nassim
Publication year - 2012
Publication title -
transplant international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.998
H-Index - 82
eISSN - 1432-2277
pISSN - 0934-0874
DOI - 10.1111/j.1432-2277.2012.01535.x
Subject(s) - belatacept , medicine , urology , calcineurin , tacrolimus , renal function , regimen , kidney transplantation , kidney , transplantation , kidney transplant
Summary 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.