IIS - PI left the institution. Subjects just followed to study completion

The purpose of this study is to collect data prospectively on African American patients who are taking the immunosuppressant Envarsus post kidney transplant. We are looking to see if African American renal transplant recipients that receive Envarsus will have less tubular injury and calcenurin inhibitor toxicity compared with patients that receive tacrolimus IR.

African americans have the higher rates of CYP3A5 which is associated with the need of higher tacrolimus dose to achieve an adequate level and this many times is associated with signs and symptoms of tacrolimus toxicity such as tremors, headaches and neuropathies.

The retrospective cohort will be African American patients that will be matched by age, gender, type of kidney transplant (living vs deceased) and level of sensitization

Inclusion Criteria:

1. African American race
2. Adult renal transplant recipients (>18 y/o)
3. Previous adverse reaction or contraindication to the use of tacrolimus

Exclusion Criteria:

1. Non African American race
2. Less than 18 y/o (pediatric patients)
3. Recipients of liver and small bowel transplants
4. Adverse reaction to tacrolimus

Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first

No difference from clinicaltrials.gov definition

The PI of this study left the institution before the study was completed. Patients were followed until the completion of the study if applicable, but no study data analysis was performed.