Blood Concentration of Tacrolimus MetabolitesSTABILE 2NCT05277792
Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients
An observational study of Blood Concentration of Tacrolimus Metabolites, run by Rennes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to evaluate if concentration of tacrolimus metabolites is increased in patients presenting tacrolimus (TAC) side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Concentration of Tacrolimus Metabolites
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 8 May 2022to 8 Jun 2024
- 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 transplant patients
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
- Associated transplantation of another organ
- Contraindications to TAC administration
- Delayed introduction of TAC (beyond the 5th postoperative day) whatever the cause.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Rennes
Rennes, 35033
Michel RAYAR, MD-PhD, 299288498 ext. +33, michel.rayar@chu-rennes.fr
About this study
The purpose of this study is to evaluate if concentration of tacrolimus metabolites is increased in patients presenting tacrolimus (TAC) side effects.
Read the detailed description
The study will evaluate whether the blood concentration of TAC metabolites (13-O-desmethyl-tacrolimus, 15-O-desmethyl-tacrolimus and 31-O-desmethyl-tacrolimus), measured between Day1 and Day5 of its introduction, is increased in patients with TAC toxicity.
A blood test will be performed daily from Day1 to Day5 for the measurement of TAC concentration and TAC metabolites concentration.
- Keywords
- Tacrolimus, metabolites, liver transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start8 May 2022
- Primary completion8 Jun 2024 (estimated)
- Study completion8 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Concentration of Tacrolimus MetabolitesStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277792
- Sponsor's protocol ID
- 35RC20_8890_STABILE 2
- Acronym
- STABILE 2
- Status last verified
- Jul 2023
- First submitted
- 3 Mar 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT05277792
- Acronym / sponsor ID
- STABILE 2 / 35RC20_8890_STABILE 2
- Keywords
- Tacrolimus, metabolites, liver transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 8 May 2022 (actual)
- Primary completion
- 8 Jun 2024 (estimated)
- Study completion
- 8 Jun 2024 (estimated)
- First posted
- 14 Mar 2022 (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.
The purpose of this study is to evaluate if concentration of tacrolimus metabolites is increased in patients presenting tacrolimus (TAC) side effects.
Detailed description
The study will evaluate whether the blood concentration of TAC metabolites (13-O-desmethyl-tacrolimus, 15-O-desmethyl-tacrolimus and 31-O-desmethyl-tacrolimus), measured between Day1 and Day5 of its introduction, is increased in patients with TAC toxicity.
A blood test will be performed daily from Day1 to Day5 for the measurement of TAC concentration and TAC metabolites concentration.
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 transplant patients
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 (3 listed)
- Associated transplantation of another organ
- Contraindications to TAC administration
- Delayed introduction of TAC (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.
Primary outcome
Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not.
Time frame: Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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.
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 Blood Concentration of Tacrolimus Metabolites, 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 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: status not confirmed, as of the sponsor's last update on 28 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel RAYAR, MD-PhD (299288498 ext. +33, michel.rayar@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not. (time frame: Day 5). 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 Jul 2023.