Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants

There are several medicines that are given to kidney transplant patients to prevent the body's immune system from rejecting (not accepting) the transplanted kidney. Frequently, more than one medicine is used at the same time to prevent rejection after kidney transplant. Some of the medicines currently used are IR-TAC, Mycophenolate mofetil (MMF), Mycophenolate sodium (MPS), and corticosteroids. IR-TAC is currently approved by the Food and Drug Administration (FDA) under the trade name of Prograf® or equivalent generic versions to prevent rejection in kidney transplant recipients. IR-TAC is taken twice daily (12 hours apart), and the dose is adjusted by the transplant provider to keep the level of tacrolimus in the blood from being too low or too high.

LCPT is a tablet containing the same active ingredient that is in IR-TAC but LCPT has been designed to release tacrolimus over a longer period of time so that it only has to be taken once a day in the morning. The dose of it is also adjusted by the transplant provider to keep the level of tacrolimus in the blood from being too low or too high. It has been approved by the FDA for prevention of rejection in kidney transplant recipients in combination with other medications to prevent rejection after kidney transplant.

In this study, the participants will be randomly assigned by chance (like flipping a coin) to receive either IR-TAC or LCPT from the time of transplant-on. Approximately half (30) of the study participants will be given IR-TAC and half will be given LCPT. Both the study participants and the transplant providers will know which medication that the participants are receiving. The participants will remain in the study for up to 12 months during which time they will be seen for monthly clinic visits, and complete labs per the standard of care.

Additionally, the study investigators will take an additional blood sample to further find out how the body absorbs and breaks down the medication tacrolimus. Participants will also undergo non-invasive pulse wave velocity and vascular compliance measurements within 3 days of post transplant, then 1 month and 12 months after transplant. Pulse wave velocity and vascular compliance measurements are two non-invasive tests that are used to evaluate how well the blood vessels adapt to each heartbeat. All participants will also be taking either Mycophenolate mofetil (MMF) or Mycophenolate sodium (MPS) and corticosteroids to prevent rejection. These procedures will help the investigators to look at the effectiveness and safety of LCPT compared to IR-TAC after kidney transplant.