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.

Inclusion Criteria:

- Subjects who are African American (Self-reported patients of Black African descent who
live in the United States)

- Subjects receiving a first or second deceased donor or living donor kidney transplant
at the Hospital of the University of Pennsylvania

- Subjects whose concurrent immunosuppression at the time of transplant will be (generic
or brand formulation) Mycophenolate mofetil (MMF, CellCept®) or mycophenolic sodium
(MPS, Myfortic®), prednisone and induction with rabbit-antithymocyte globulin
(Thymoglobulin®)

Exclusion Criteria:

- Subjects who are greater than 75 years old

- Subjects who are not self-described as being of Black African descent and living in
the United States

- Subjects who are recipients of organ transplants other than kidney

- Subjects who are recipients of third time or more kidney transplants

- Subjects who are HIV positive at the time of pre-transplant screening

- Subjects with recurrent focal segmental glomerulosclerosis (FSGS)