Envarsus XR in African American Renal Transplant Recipients

Stopped early · Not applicable

Conditions studied: Renal Transplant Recipients

In brief

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

Key facts

Study ID

NCT02956005

Run by

Georgetown University

People needed

18

Starts

2016-09-01

Expected to finish

2018-09-01

Last updated by the study team

2020-03-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Medstar Georgetown Transplant Institute — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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