Liver TransplantationOPTILTHNCT02877628
Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation
An observational study of Liver Transplantation, run by Rennes University Hospital at 1 site in France.
Trial summary
Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to clinicians or patients during the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Pharmacokinetic-pharmacodynamic model in liver transplantation
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2015to Dec 2018
- 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: Patient with liver tranplantation
Who may be able to join
- Adults over 18
- Liver transplant recipients
- Treated with an immunosuppressive protocol with tacrolimus
- Informed on the study and who did not refuse to participate
Who cannot join
- Patients who participate in a study with procedures incompatible with the present study.
- Patients with legal protection/deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to clinicians or patients during the study.
- Conditions
- Liver Transplantation
- Being tested
- Pharmacokinetic-pharmacodynamic model in liver transplantation
- Keywords
- pharmacokinetic, pharmacodynamic, tacrolimus, CYP3A5, liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic-pharmacodynamic model in liver transplantationOther
Biological: tacrolimus and calcineurin dosage, donor and recipient CYP3A5 and ABCB1 genotypes determination
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
Assessement of the relationships between tacrolimus dosage, whole-blood and intracellular concentrations
Measured: Week 24
Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
Assessement of the relationships between intracellular concentrations of tacrolimus and calcineurin activity
Measured: Week 24
Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
Assessement of the relationships between donor and recipient CYP3A5 and ABCB1 genotypes and dose/concentration of tacrolimus
Measured: Week 24
Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
Assessement of the relationships between intracellular concentration of tacrolimus and/or calcineurin activity and ACR, in patients treated with immediate release or modified-release formulation of tacrolimus
Measured: Week 24
Secondary outcomes (3)
Study of impact of pharmacogenetic and demographic data on tacrolimus intracellular concentration
Measured: Week 24
Evaluation of the role of the measurement of intracellular concentration as a longitudinal biomarker in preventing acute cellular graft (ACR)
Measured: Week 24
Study of variability of tacrolimus intracellular concentration according to its pharmaceutic form (immediate or sustained release)
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start31 Oct 2015
- Primary completion29 Nov 2018
- Study completionDec 2018
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
- 110 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
- NCT02877628
- Sponsor's protocol ID
- 35RC13_8962_OPTILTH
- Acronym
- OPTILTH
- Status last verified
- Jan 2019
- First submitted
- 16 Aug 2016
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation
- ClinicalTrials.gov ID
- NCT02877628
- Acronym / sponsor ID
- OPTILTH / 35RC13_8962_OPTILTH
- Conditions
- Liver Transplantation
- Keywords
- pharmacokinetic, pharmacodynamic, tacrolimus, CYP3A5, liver transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 31 Oct 2015 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 24 Aug 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.
Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to clinicians or patients during the study.
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
- Patient with liver tranplantation
Key inclusion criteria (4 listed)
- Adults over 18
- Liver transplant recipients
- Treated with an immunosuppressive protocol with tacrolimus
- Informed on the study and who did not refuse to participate
Key exclusion criteria (2 listed)
- Patients who participate in a study with procedures incompatible with the present study.
- Patients with legal protection/deprived of liberty.
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 |
|---|---|---|
| Pharmacokinetic-pharmacodynamic model in liver transplantationBiological: tacrolimus and calcineurin dosage, donor and recipient CYP3A5 and ABCB1 genotypes determination | Other | – |
Primary outcome
Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
Time frame: Week 24
Assessement of the relationships between tacrolimus dosage, whole-blood and intracellular concentrations
Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
Time frame: Week 24
Assessement of the relationships between intracellular concentrations of tacrolimus and calcineurin activity
Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
Time frame: Week 24
Assessement of the relationships between donor and recipient CYP3A5 and ABCB1 genotypes and dose/concentration of tacrolimus
Prediction of calcineurin inhibition, responsible for the immunosuppressive effect
Time frame: Week 24
Assessement of the relationships between intracellular concentration of tacrolimus and/or calcineurin activity and ACR, in patients treated with immediate release or modified-release formulation of tacrolimus
3 secondary outcomes
Study of impact of pharmacogenetic and demographic data on tacrolimus intracellular concentration
Time frame: Week 24
Evaluation of the role of the measurement of intracellular concentration as a longitudinal biomarker in preventing acute cellular graft (ACR)
Time frame: Week 24
Study of variability of tacrolimus intracellular concentration according to its pharmaceutic form (immediate or sustained release)
Time frame: Week 24
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 28 Jan 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.
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 Liver 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 4 inclusion and 2 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 28 Jan 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 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?
Prediction of calcineurin inhibition, responsible for the immunosuppressive effect (time frame: Week 24). The study lists 4 primary outcomes in all. 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 28 Jan 2019.