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Drug Interaction With Envarsus XR and Grapefruit Juice

Kidney Transplant; Complications Clinical Trial

Official title:
Assessment of the Intestinal CYP3A Contribution to Drug Interactions With Envarsus XR Using Grapefruit Juice

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03916380
Study type Interventional
Source University of California, San Diego
Contact Shirley M Tsunoda, Pharm.D.
Phone 858-822-6629
Email smtsunoda@ucsd.edu
Status Not yet recruiting
Phase Phase 4
Start date May 31, 2019
Completion date June 30, 2020
View Details
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