NCT02956005

Envarsus XR in African American Renal Transplant Recipients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Renal Transplant Recipients

Interventions

Type	Name	Description
DRUG	ENVARSUS®	ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-11-04
• Last updated: 2020-03-24
• Results posted: 2020-03-24

Locations

1 site across 1 country: United States