Belatacept 3 Month Post Transplant Conversion Study
Status:
Completed
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
Summary
This study is being done to investigate the impact of changing immunosuppressive medications
from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months
after kidney transplantation. The immune system is the body's defense against infection and
other disease. After transplantation, the body sees the new organ as "foreign" and tries to
destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from
attacking the transplanted organ. The primary purpose of this research study is to evaluate
the effects of three (3) different immunosuppressive treatments on rejection in
post-transplant kidney recipients. This study will test whether switching from tacrolimus to
belatacept will improve long-term kidney function.
Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate
mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug
Administration (FDA) to be used after transplant. All of these medications have been
routinely used in kidney recipients here at Northwestern University.
Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant.
However, the use of belatacept in this study is considered investigational as it has not been
FDA approved for use beginning at 3 months after transplant.
This study will involve 51 adult kidney transplant recipients at Northwestern.