Envarsus XR in African American Renal Transplant Recipients (EXR)

Georgetown University

Status: Terminated

Conditions: Renal Transplant Recipients

Treatments: Drug: ENVARSUS®

Study type: Interventional

Funder types: Other

Identifiers

NCT02956005

EXR1

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

Envarsus

Other group

Description:

Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL

Treatment:

Drug: ENVARSUS®