Biliary Concentration of TacrolimusSTABILENCT02820259
Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)
An observational study of Biliary Concentration of Tacrolimus, run by Rennes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to demonstrate that the biliary concentration of TCR is a good marker of its immunosuppressive activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Concentration of Tacrolimus
- What is being tested?
- Tacrolimus
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2016to 7 Apr 2017
- 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: liver-transplanted patients who receive tacrolimus
Who may be able to join
- Adult patients (> 18 years) of both sexes,
- Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease,
- Not having expressed their opposition to participation in the study
Who cannot join
- Bilio-enteric anastomosis,
- Associated transplantation of another organ
- Contraindications to TCR administration
- Delayed introduction of TCR (beyond the 5th postoperative day) whatever the cause.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to demonstrate that the biliary concentration of TCR is a good marker of its immunosuppressive activity.
- Conditions
- Biliary Concentration of Tacrolimus
- Being tested
- Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC
Measured: during the first 7 days after its initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start1 May 2016
- Primary completion7 Apr 2017
- Study completion7 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary Concentration of TacrolimusStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820259
- Sponsor's protocol ID
- 35RC16_9755
- Acronym
- STABILE
- Status last verified
- Sep 2017
- First submitted
- 24 Jun 2016
- Last updated
- 25 Sep 2017
- Results posted
- No
Publications
Rayar M, Tron C, Locher C, Chebaro A, Beaurepaire JM, Blondeau M, Cusumano C, Bardou-Jacquet E, Houssel-Debry P, Camus C, Petitcollin A, Verdier MC, Lakehal M, Desfourneaux V, Sulpice L, Meunier B, Bellissant E, Boudjema K, Lemaitre F. Tacrolimus Concentrations Measured in Excreted Bile in Liver Transplant Recipients: The STABILE Study. Clin Ther. 2018 Dec;40(12):2088-2098. doi: 10.1016/j.clinthera.2018.10.015. Epub 2018 Nov 19.
PubMed 30467013
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)
- ClinicalTrials.gov ID
- NCT02820259
- Acronym / sponsor ID
- STABILE / 35RC16_9755
- Conditions
- Biliary Concentration of Tacrolimus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 May 2016
- Primary completion
- 7 Apr 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 30 Jun 2016 (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.
The purpose of this study is to demonstrate that the biliary concentration of TCR is a good marker of its immunosuppressive activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- liver-transplanted patients who receive tacrolimus
Key inclusion criteria (3 listed)
- Adult patients (> 18 years) of both sexes,
- Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease,
- Not having expressed their opposition to participation in the study
Key exclusion criteria (4 listed)
- Bilio-enteric anastomosis,
- Associated transplantation of another organ
- Contraindications to TCR administration
- Delayed introduction of TCR (beyond the 5th postoperative day) whatever the cause.
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 |
|---|---|---|
| Tacrolimus | Drug | – |
Primary outcome
coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC
Time frame: during the first 7 days after its initiation
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 25 Sep 2017.
- Derived from this study: PubMed 30467013Rayar M, Tron C, Locher C, Chebaro A, Beaurepaire JM, Blondeau M, Cusumano C, Bardou-Jacquet E, Houssel-Debry P, Camus C, Petitcollin A, Verdier MC, Lakehal M, Desfourneaux V, Sulpice L, Meunier B, Bellissant E, Boudjema K, Lemaitre F. Tacrolimus Concentrations Measured in Excreted Bile in Liver Transplant Recipients: The STABILE Study. Clin Ther. 2018 Dec;40(12):2088-2098. doi: 10.1016/j.clinthera.2018.10.015. Epub 2018 Nov 19.
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 Biliary Concentration of Tacrolimus, run by Rennes University Hospital at 1 site in France.
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 4 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 25 Sep 2017. 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 France. 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?
coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC (time frame: during the first 7 days after its initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820259, which also lists 1 linked publication.
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 25 Sep 2017.