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OpenTrials
Completed

NCT Number: NCT03916380

Drug Interaction With Envarsus XR and Grapefruit Juice

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.

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Key information

Conditions

Kidney Transplant; Complications Drug Interaction Food

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC San Diego Health

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grapefruit Juice

Dietary Supplement

Single 8 ounce administration of oral grapefruit juice

Primary outcomes

  1. Tacrolimus AUC before and after Grapefruit Juice

    Time frame: 2-4 weeks

Secondary outcomes

  1. Tacrolimus AUC compared to Midazolam AUC

    Time frame: 2-4 weeks

Sponsors and collaborators

Lead sponsor

Shirley M. Tsunoda

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Apr 16, 2019
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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