Drug Interaction With Envarsus XR and Grapefruit Juice

Shirley M. Tsunoda11 enrolled

Overview

Transplant patients must take lifelong immunosuppression in order to prevent rejection of their organ. Tacrolimus is the most widely used immnosuppressive agent. Part of the routine education given to patients regarding tacrolimus is that they must avoid many drugs and substances that can interact with tacrolimus so that they don't experience side effects or lack of effect. Patients are told they must avoid readily available substances such as grapefruit juice and St. John's wort. A new once daily formulation of tacrolimus, Envarsus XR, may bypass the place in the gut in which many of these drug interactions occur. We will give kidney transplant patients Envarsus with and without grapefruit juice and measure the effect on blood levels throughout the day. Results from this study will also give us information about the likelihood of other drugs interacting with Envarsus XR.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Kidney Transplant; Complications Drug Interaction Food

Interventions

Grapefruit Juice

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary Kidney Transplant Age \> 18 years At least 3 months post-transplantation Taking a stable dose of tacrolimus extended release with a target trough of 8-10 ng/mL BMI between 18-32 Exclusion Criteria: * Multi-organ transplant Concomitant use of mTOR inhibitor Concomitant use of belatacept Concomitant use of medication affecting CYP3A or P-gp History of rejection Hypersensitivity to midazolam Hypersensitivity to Envarsus Active diarrhea or constipation BMI \< 18 or \> 32

Outcomes

Primary Outcomes

Tacrolimus AUC before and after Grapefruit Juice

Time frame: 2-4 weeks

Secondary Outcomes

Tacrolimus AUC compared to Midazolam AUC