Drug InteractionsPhase 4NCT02576366
Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus
A Phase 4 study testing Voriconazole and Rifampin in people with Drug Interactions and Kidney Transplantation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Single center, open label crossover study with 2 treatment phases in healthy volunteers. The potential of phenotypic drug probes to predict drug-drug interactions between tacrolimus, voriconazole and rifampin will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Interactions, Kidney Transplantation
- What is being tested?
- Voriconazole and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to Dec 2017
- Phase
- Phase 4
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Age over 18 years
- Written informed consent
Who cannot join
- Female
- Medical comorbidities
- Use of concomitant medication
Trial locations and contacts
1 site in 1 country.
About this study
Single center, open label crossover study with 2 treatment phases in healthy volunteers.
The potential of phenotypic drug probes to predict drug-drug interactions between tacrolimus, voriconazole and rifampin will be assessed.
- Conditions
- Drug Interactions, Kidney Transplantation
- Being tested
- Voriconazole, Rifampin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoriconazoleDrug
Also called Vfend
RifampinDrug
Also called Rifadin; Rifadine
| Study group | Role | What they receive |
|---|---|---|
| Voriconazole | Experimental | Four hundred mg of voriconazole (2 tablets of 200 mg Vfend; Pfizer, Karlsruhe, Germany) will be administered twice daily on day 2. Two hundred mg of voriconazole (1 tablet of 200 mg Vfend) will be administered twice daily on days 3, 4, 5 and 6. Receives: Drug: Voriconazole |
| Rifampin | Experimental | Six hundred mg of rifampicin (2 tablets of 300mg Rifadine; Sanofi, Belgium) will be administered once daily on days 7 through 13. Receives: Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tacrolimus area under the curve
assessed twice: once after each treatment
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startJun 2016
- Primary completionMay 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk RJ Kuypers, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576366
- Sponsor's protocol ID
- TacDDI151010
- Status last verified
- Aug 2019
- First submitted
- 12 Oct 2015
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus
- ClinicalTrials.gov ID
- NCT02576366
- Acronym / sponsor ID
- TacDDI151010
- Conditions
- Drug Interactions, Kidney Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Oct 2015 (estimated)
- 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.
Single center, open label crossover study with 2 treatment phases in healthy volunteers.
The potential of phenotypic drug probes to predict drug-drug interactions between tacrolimus, voriconazole and rifampin will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voriconazole | Experimental | Drug: VoriconazoleFour hundred mg of voriconazole (2 tablets of 200 mg Vfend; Pfizer, Karlsruhe, Germany) will be administered twice daily on day 2. Two hundred mg of voriconazole (1 tablet of 200 mg Vfend) will be administered twice daily on days 3, 4, 5 and 6. |
| Rifampin | Experimental | Drug: RifampinSix hundred mg of rifampicin (2 tablets of 300mg Rifadine; Sanofi, Belgium) will be administered once daily on days 7 through 13. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male
- Age over 18 years
- Written informed consent
Key exclusion criteria (3 listed)
- Female
- Medical comorbidities
- Use of concomitant medication
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 |
|---|---|---|
| VoriconazoleAlso: Vfend | Drug | Voriconazole |
| RifampinAlso: Rifadin; Rifadine | Drug | Rifampin |
Primary outcome
Change in tacrolimus area under the curve
Time frame: 2 weeks
assessed twice: once after each treatment
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 22 Aug 2019.
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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.
Dirk RJ Kuypers, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Voriconazole and Rifampin in people with Drug Interactions and Kidney Transplantation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 inclusion and 3 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 22 Aug 2019. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in tacrolimus area under the curve (time frame: 2 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 22 Aug 2019.