Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix (belatacept)-based Immunosuppression
The major class of anti rejection drugs used for kidney transplant recipients are the Calcineurin Inhibitors which include cyclosporine and tacrolimus. These drugs have side effets including renal injury and therefore the development of newer antirejection drugs continues. One new drug recently approved for prophylaxis againts rejection in the kidney transplant recipient is belatacept. This drug works by a different mechanism of action and is given intravenously at approximately one month intervals after the initial doses. The purpose of ths study is to evaluate belatacept in renal transplant recipients who are converted from a calcineurin inhibitor to belatacept and administered the drug over a two year period. Participants will be randomized 1:1 to either remain on the calcineurin inhibitor or convert to belatacept. Both groups will receive mycophenolate mofetil (or another similar agent) and steroids which are routinely used in this patient population. Participants will be closely monitored over the next two years and for an additional period thereafter for adverse events, renal function, and rejection episodes. Post tranplant lymphoproliferative disease is a complicaton of immunosuppression and it was found in prior studies that there were more cases in patients randomized to belatacept that calcineurin inhibitorrs. In addition, there was more involved of the central nervous system. The group at greatest risk were patients who had negative serology for EBV and these were therefore excluded from studies later on. Particular attention will be paid to monitoring for post-transplant lymphoproliferative disease through exams, neurologic assessments and additonal evaluation as indicated. The sponsor will conduct the statistical analysis to compare renal function, graft survival, rejection and adverse events.
EVALUATING NULOJIX LONG TERM SAFETY IN TRANSPLANT
Chronic kidney disease (CKD) affects a large proportion of the United States population;in 2008 there were approximately 15.8 million patients with CKD. Kidney transplant is the treatment of choice for patients with ESRD. The introduction of immunosuppressive agents has greatly improved short-term allograft survival, and renal transplant patients are surviving longer. There are a variety of different immunosuppressive regimens that are utilized.This study is a prospective voluntary multi-center registry with a purpose to determine the incidence rate of confirmed PTLD, CNS PTLD and PML in the adult kidney transplant recipients, regardless of EBV serostatus, who receive belatacept following a kidney transplant (de novo) and those who switch to belatacept after other therapies. Subjects who are enrolled to the study will be followed for a minimum of two years.All data will be submitted to the sponsor who will perform the statistical analysis of the data.