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

• At least 18 years of age
• Signed informed consent
• African American race
• History of a solitary renal transplant
• Stable tacrolimus dose for at least 2 weeks prior to randomization

Exclusion criteria

• 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
• Currently enrolled in an investigational drug trial
• History of a non-renal organ transplant
• History of acute cellular rejection within 1 month prior to randomization
• An increase in serum creatinine by > 20% in the 2 weeks prior to randomization
• 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