Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients

The purpose of this study is to compare the difference in medication dosage and total daily
dose necessary of Astagraf XL® in order to reach therapy goal, when taken with other
medications that are routinely used for kidney transplantation, which may stop the
development of a substance that can cause long-term damage to the transplanted kidney.
African American kidney transplant patients aged 18 and above who are underwent a kidney
transplant are eligible to participate. The duration of the study is 3 months.

Inclusion Criteria:

1. At least 18 years of age

2. Signed informed consent

3. African American race

4. History of a solitary renal transplant

5. Stable tacrolimus dose for at least 2 weeks prior to randomization

Exclusion Criteria:

1. A condition or disorder that, in the opinion of the investigator, may adversely affect
the outcome of the study or the safety of the subject

2. Currently enrolled in an investigational drug trial

3. History of a non-renal organ transplant

4. History of acute cellular rejection within 1 month prior to randomization

5. An increase in serum creatinine by > 20% in the 2 weeks prior to randomization

6. Maintenance immunosuppression that does not consist of tacrolimus IR given twice
daily, mycophenolate mofetil > 1000mg TDD or mycophenolate sodium > 720mg TDD, and
prednisone ≥ 5mg daily