Liver TransplantationTRANS-TACNCT03910868
Impact of P-gp, MRP2, ENT-1 and CNT3 on the Blood Concentration / Intra-PBMC Concentration of Tacrolimus
An observational study of Liver Transplantation and Kidney Transplantation, run by Rennes University Hospital at 1 site in France.
Trial summary
Prospective and monocentric pharmacokinetic study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Kidney Transplantation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2020to 16 Dec 2020
- 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: Hepatic and / or renal transplantation
Who may be able to join
- Adult of 18 or over;
- fully and honestly informed, and not having reported his non-opposition to the use of his samples for research;
- Affiliated to a social security scheme;
- Hepatic and / or renal transplant stable between two and twenty-four months after transplantation, treated with tacrolimus;
- Without modification of immunosuppressive treatment or treatment likely to modify their pharmacokinetics (imidazoles, macrolides ...) during the last two weeks;
- Each patient can only be included once.
Who cannot join
- Participation in another protocol whose procedures are incompatible with the realization of the study;
- Pregnant woman ;
- Major person subject to legal protection (safeguard of justice, guardianship, tutorship);
- Person deprived of liberty;
- Opposition to the use of clinical data and remnants of samples taken from care for research purposes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Impact of P-gp, MRP2, ENT-1 and CNT3 on the Blood Concentration / Intra-PBMC Concentration of Tacrolimus in Liver and Kidney Transplant Patients
Prospective and monocentric pharmacokinetic study
Read the detailed description
Membrane transporters supporting tacrolimus at the lymphocyte level may play a role in the variability of the relationship between tacrolimus blood concentration and intracellular concentration, or may be the main explanatory factors. Nevertheless, most of the studies carried out on the subject, have been by genetic approach, neglecting in fact the membrane expression of these transporters, which could testify more to the real effect on the transport of tacrolimus. A better understanding of the cellular transport mechanisms of tacrolimus in the T lymphocyte could thus make it possible to identify sub-populations of patients under-exposed at the intra-lymphocyte level, despite satisfactory systemic exposure.
- Conditions
- Liver Transplantation, Kidney Transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between drug transporters expression (RNA and protein) in PBMC and tacrolimus intra-PBMC concentration
The mRNA levels will be recorded as a cycle threshold difference between the studied gene, and the mean of two housekeeping genes (ACTB and B2M). The proteic expression of the studied transporters will be recorded as fluorescent intensity levels
Measured: During the consultation (between 2 and 24 months after the transplant)
Secondary outcomes (5)
Correlation between drug transporters RNA expression in PBMC and drug transporters protein expression in PBMC
The mRNA levels will be recorded as a cycle threshold difference between the studied gene, and the mean of two housekeeping genes (ACTB and B2M). The proteic expression of the studied transporters will be recorded as fluorescent intensity levels
Measured: During the consultation (between 2 and 24 months after the transplant)
Correlation between tacrolimus blood to intracellular ratio and adverse events.
Tacrolimus-related adverse effects as recorded on the medical record of the patient.
Measured: During the consultation (between 2 and 24 months after the transplant)
Correlation between tacrolimus intra-PBMC concentration and treatment outcome
Treatment outcome as recorded on the medical record of the patient.
Measured: During the consultation (between 2 and 24 months after the transplant)
Correlation between tacrolimus intra-PBMC concentration and comedications
Co-medications as recorded on the medical record of the patient.
Measured: During the consultation (between 2 and 24 months after the transplant)
Correlation between tacrolimus intra-PBMC concentrations and Donor Graft cell-free DNA (cf-DNA) concentration
Donor graft cf-DNA characterized the cell death marker, released from necrotic or apoptotic cells in the transplant organ, and may therefore be useful as a marker for graft injury. When its plasma concentration increases, it evidences that a lesion process occurs in the graft
Measured: During the consultation (between 2 and 24 months after the transplant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start16 Jul 2020
- Primary completion16 Dec 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian LEMAITRE, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910868
- Sponsor's protocol ID
- 35RC19_30018_TRANS-TAC
- Acronym
- TRANS-TAC
- Status last verified
- Jan 2021
- First submitted
- 4 Apr 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of P-gp, MRP2, ENT-1 and CNT3 on the Blood Concentration / Intra-PBMC Concentration of Tacrolimus in Liver and Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT03910868
- Acronym / sponsor ID
- TRANS-TAC / 35RC19_30018_TRANS-TAC
- Conditions
- Liver Transplantation, Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 10 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.
Prospective and monocentric pharmacokinetic study
Detailed description
Membrane transporters supporting tacrolimus at the lymphocyte level may play a role in the variability of the relationship between tacrolimus blood concentration and intracellular concentration, or may be the main explanatory factors. Nevertheless, most of the studies carried out on the subject, have been by genetic approach, neglecting in fact the membrane expression of these transporters, which could testify more to the real effect on the transport of tacrolimus. A better understanding of the cellular transport mechanisms of tacrolimus in the T lymphocyte could thus make it possible to identify sub-populations of patients under-exposed at the intra-lymphocyte level, despite satisfactory systemic exposure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatic and / or renal transplantation
Key inclusion criteria (6 listed)
- Adult of 18 or over;
- fully and honestly informed, and not having reported his non-opposition to the use of his samples for research;
- Affiliated to a social security scheme;
- Hepatic and / or renal transplant stable between two and twenty-four months after transplantation, treated with tacrolimus;
- Without modification of immunosuppressive treatment or treatment likely to modify their pharmacokinetics (imidazoles, macrolides ...) during the last two weeks;
Key exclusion criteria (5 listed)
- Participation in another protocol whose procedures are incompatible with the realization of the study;
- Pregnant woman ;
- Major person subject to legal protection (safeguard of justice, guardianship, tutorship);
- Person deprived of liberty;
- Opposition to the use of clinical data and remnants of samples taken from care for research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between drug transporters expression (RNA and protein) in PBMC and tacrolimus intra-PBMC concentration
Time frame: During the consultation (between 2 and 24 months after the transplant)
The mRNA levels will be recorded as a cycle threshold difference between the studied gene, and the mean of two housekeeping genes (ACTB and B2M). The proteic expression of the studied transporters will be recorded as fluorescent intensity levels
5 secondary outcomes
Correlation between drug transporters RNA expression in PBMC and drug transporters protein expression in PBMC
Time frame: During the consultation (between 2 and 24 months after the transplant)
Correlation between tacrolimus blood to intracellular ratio and adverse events.
Time frame: During the consultation (between 2 and 24 months after the transplant)
Correlation between tacrolimus intra-PBMC concentration and treatment outcome
Time frame: During the consultation (between 2 and 24 months after the transplant)
Correlation between tacrolimus intra-PBMC concentration and comedications
Time frame: During the consultation (between 2 and 24 months after the transplant)
Correlation between tacrolimus intra-PBMC concentrations and Donor Graft cell-free DNA (cf-DNA) concentration
Time frame: During the consultation (between 2 and 24 months after the transplant)
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 13 Jan 2021.
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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.
Florian LEMAITRE principal investigator
Rennes University Hospital
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 Liver Transplantation and Kidney Transplantation, 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 6 inclusion and 5 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 13 Jan 2021. 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?
Correlation between drug transporters expression (RNA and protein) in PBMC and tacrolimus intra-PBMC concentration (time frame: During the consultation (between 2 and 24 months after the transplant)). 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 13 Jan 2021.