Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations

Myfortic® is an enteric-coated formulation of the sodium salt derivative of mycophenolic
acid (MPA) that is administered to control kidney graft rejection. Myfortic® was developed
to improve MPA-related upper gastrointestinal (GI) side effects by delaying the release of
MPA until it reaches the large surface of the small bowel. Approximately half of all the
kidney transplant recipients in the United States have diabetes mellitus. A recent analysis
of approximately 30,000 kidney transplant recipients included in the U.S. Renal Data System
showed that 42% of patients had pre-transplant diabetes (1). Moreover, 15% to 20% of
patients develop diabetes after transplantation, a condition that is commonly known as
post-diabetes mellitus (1-3). It was previously shown that the rate and extent of MPA
absorption is minimally affected by diabetes (4). Limited data is available in the current
literature on Myfortic® and Simulect® based therapy in diabetic patients.

Inclusion Criteria:

1. Adults (age 18 to 65 years of age), male or female Hispanic or Caucasian.

2. Primary kidney or kidney transplant patients (cadaveric, living related, or living
unrelated)

3. Written inform consent obtained. The patients are willing to participate in the study
at UTMB.

4. Female with negative pregnancy test.

5. PRA < 20 %.

6. En-blocks and two kidneys (tx'd at the same time) will be allowed.

7. Cold Ischemia time ≤ 30 hrs

8. Hep C patients will be allowed to enroll in this study

Exclusion Criteria:

1. Multi-organ transplants

2. Transplant from non-heart beating donor (NHBD) or dual transplants

3. A-B-O incompatible or positive cross match

4. Conditions which significantly alter the absorption, distribution, and metabolism
(except for diarrhea) of medications.

5. Women of childbearing potential not using contraception method(s) as well as women
who are breastfeeding

6. Inability to tolerate oral medications

7. Inability to sign a written consent form or to cooperate with investigators

8. Use of an investigational medication in the past 30 days.

9. Patients with severe medical condition(s) that in the view of the investigator
prohibits participation in the study (specify as required)

10. HIV positive patients

11. History of psychosocial instability

12. Mental incompetence