Kidney Transplant; ComplicationsNCT03916380
Drug Interaction With Envarsus XR and Grapefruit Juice
An observational study of Kidney Transplant; Complications and Drug Interaction Food, run by Shirley M. Tsunoda at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Drug Interaction Food
- What is being tested?
- Grapefruit Juice
- Type of treatment
- Pill or oral medicine
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (18 years and older) recipients of a primary kidney transplant who are at least 3 months post-transplantation. Patients will be enrolled as outpatients in the abdominal transplant clinic. For the pharmacokinetic study days at Visit A and Visit B, patients will be outpatients at the UCSD Clinical and Translational Research Institute (CTRI). It is anticipated that we will need to screen approximately 60 patients in order to enroll 20. Since we perform approximately 80-100 kidney transplants per year at UCSD Health, we anticipate enrollment will take 6-10 months. Reasons for patients not participating in the study include: not meeting the inclusion/exclusion criteria; not able or willing to participate in the study because of the time commitment; dropping out. If patients drop out of the study, we will replace them with consecutive patients as they become eligible.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Intestinal CYP3A Contribution to Drug Interactions With Envarsus XR Using 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.
- Being tested
- Grapefruit Juice
- Keywords
- Tacrolimus, Grapefruit Juice, CYP3A4, Midazolam, Kidney Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grapefruit JuiceDietary supplement
Single 8 ounce administration of oral grapefruit juice
| Study group | Role | What they receive |
|---|---|---|
| Group A | Tacrolimus Extended Release + Midazolam Receives: Dietary Supplement: Grapefruit Juice | |
| Group B | Tacrolimus Extended Release + Midazolam + Grapefruit Juice Receives: Dietary Supplement: Grapefruit Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tacrolimus AUC before and after Grapefruit Juice
Measured: 2-4 weeks
Secondary outcomes (1)
Tacrolimus AUC compared to Midazolam AUC
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start25 Oct 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley M. Tsunoda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shirley M. Tsunoda, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916380
- Sponsor's protocol ID
- 190617
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2019
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Intestinal CYP3A Contribution to Drug Interactions With Envarsus XR Using Grapefruit Juice
- ClinicalTrials.gov ID
- NCT03916380
- Acronym / sponsor ID
- 190617
- Keywords
- Tacrolimus, Grapefruit Juice, CYP3A4, Midazolam, Kidney Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Shirley M. TsunodaUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Dietary Supplement: Grapefruit JuiceTacrolimus Extended Release + Midazolam |
| Group B | – | Dietary Supplement: Grapefruit JuiceTacrolimus Extended Release + Midazolam + Grapefruit Juice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (18 years and older) recipients of a primary kidney transplant who are at least 3 months post-transplantation. Patients will be enrolled as outpatients in the abdominal transplant clinic. For the pharmacokinetic study days at Visit A and Visit B, patients will be outpatients at the UCSD Clinical and Translational Research Institute (CTRI). It is anticipated that we will need to screen approximately 60 patients in order to enroll 20. Since we perform approximately 80-100 kidney transplants per year at UCSD Health, we anticipate enrollment will take 6-10 months. Reasons for patients not participating in the study include: not meeting the inclusion/exclusion criteria; not able or willing to participate in the study because of the time commitment; dropping out. If patients drop out of the study, we will replace them with consecutive patients as they become eligible.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grapefruit JuiceSingle 8 ounce administration of oral grapefruit juice | Dietary supplement | Group A, Group B |
Primary outcome
Tacrolimus AUC before and after Grapefruit Juice
Time frame: 2-4 weeks
1 secondary outcome
Tacrolimus AUC compared to Midazolam AUC
Time frame: 2-4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant; Complications
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant; Complications and Drug Interaction Food, run by Shirley M. Tsunoda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tacrolimus AUC before and after Grapefruit Juice (time frame: 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.