Clinical Studies on Renal Transplantation
For the transplant population we have the following studies:
BMS IM103116 - This is a 24 month randomized trial. Subjects will be randomized to continue their current CNI or converted to Belatacept. Previous studies have shown that subjects could be converted from CNI to belatacept without an increased risk of death or graft loss. These subjects showed improvement in renal function through Month 36 post randomization, there was no evidence of proteinuria or increased infections and they experienced less side effects.
ENLiST Registry - Studied population in this registry will consist of adult de novo patients treated with belatacept for a kidney transplant in routine clinical practice in the US as determined by treating clinicians.
CMX001–307 - A Phase 3 study with the primary objectives of
- To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of CMV disease in kidney transplant allograft recipients who are CMV-seropositive pre transplant and received antilymphocyte induction therapy.
- To compare the safety and tolerability of BCV to vGCV in kidney transplant recipients who received antilymphocyte induction therapy
CMX001–303 - A Phase 3 study with the primary objectives of:
- To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are high-risk for CMV disease (CMV-seronegative pre-transplant and received a kidney from a CMV-seropositive donor)
- To compare the safety and tolerability of BCV to vGCV in high-risk kidney transplant allograft recipients