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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03916380
• Other study ID #: 190617
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 31, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2019
• Source: University of California, San Diego
• Contact: Shirley M Tsunoda, Pharm.D.
• Phone: 858-822-6629
• Email: smtsunoda[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Interaction Food
• Kidney Transplant; Complications

Intervention

Dietary Supplement:
• Grapefruit Juice
Single 8 ounce administration of oral grapefruit juice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shirley M. Tsunoda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tacrolimus AUC before and after Grapefruit Juice		2-4 weeks
Secondary	Tacrolimus AUC compared to Midazolam AUC		2-4 weeks