Liver Transplant; ComplicationsBBRTNCT03882164
Blood-Bile Ratio Tacrolimus After Liver Transplantation
An observational study of Liver Transplant; Complications and Immunosuppression, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Tacrolimus is the most widely used immunosuppressive drug in the prevention of rejection after solid organ transplantation. Pharmacokinetic studies in healthy volunteers and in transplanted patients have shown that this molecule is rapidly absorbed after oral administration (maximum plasma concentration after 1-2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications, Immunosuppression, Transplant Failure
- What is being tested?
- Blood-Bile Ratio of Tacrolimus
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 21 Feb 2019to May 2020
- How long will I take part?
- 10 Days
- 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: Patients undergone liver transplant with positioning of Kehr tube
Who may be able to join
- Age ≥18 years
- History of recent liver transplant (less than 10 days)
- Placement of kehr tube in the biliary tract during liver transplant
- Immunosuppressive therapy with Tacrolimus
- Functioning of kehr tube
Who cannot join
- Age - Age ≥18 years
- History of liver transplant for more than 10 days
- Liver transplant without positioning of kehr tube
- Immunosuppressive therapy with a drug different from Tacrolimus
- No functioning of kehr tube18 years
- History of liver transplant for more than 10 days
Show all 9Show fewer
- Liver transplant without positioning of kehr tube
- Immunosuppressive therapy with a drug different from Tacrolimus
- No functioning of kehr tube
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Tacrolimus Blood-bile Ratio for the Detection of Early Liver Failure After Liver Transplantation
Tacrolimus is the most widely used immunosuppressive drug in the prevention of rejection after solid organ transplantation. Pharmacokinetic studies in healthy volunteers and in transplanted patients have shown that this molecule is rapidly absorbed after oral administration (maximum plasma concentration after 1-2 hours), is found in the circulation bound mainly to erythrocytes and, after being metabolized by CYP3A4, is eliminated through the bile. The importance of the tacrolimus blood dosage is now widely recognized for detecting the immunosuppressive capacity reached in the individual patient or the eventual overdose of the drug. In the use of Tacrolimus after Liver Transplantation, however, it is interesting to note that the biochemical pathway for metabolism and excretion of the drug is present in the transplanted organ, the main object of immunological and functional surveillance. The excretory capacity of Tacrolimus by the liver through the bile, therefore, could be a useful tool for recognizing the early liver failure from a functional point of view, before the onset of hepatoecrosis.
Read the detailed description
Prospective monocentric randomized study comparing two parallel groups:
liver transplanted patients with early (10 POD) organ rejection (experimental arm); liver transplanted patients without early (10 POD) organ rejection (control arm) Primary Objective: Evaluation of a correlation between the reduction of Tacrolimus biliary excretion and the early liver failure Primary Endpoint: Increase of Tacrolimus blood-bile ratio measured before the onset of laboratory hepatonecrosis Secondary Objective: Analysis of the cause of any drug-related toxicity Secondary Endpoint: correlation study between drug dosage and biliary excretion level in case of blood overdose or clinical evidence of pharmacological toxicity
- Conditions
- Liver Transplant; Complications, Immunosuppression, Transplant Failure, Transplant; Complication, Rejection
- Being tested
- Blood-Bile Ratio of Tacrolimus
- Keywords
- Liver transplant;, Immunosuppression;, Transplant rejection;
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood-Bile Ratio of TacrolimusDiagnostic test
Diagnosis of early transplanted liver dysfunction to adjust Tacrolimus dose adminstered
| Study group | Role | What they receive |
|---|---|---|
| Rejection | Patient undergone liver transplant with diagnosis of rejection within 10 days Receives: Diagnostic Test: Blood-Bile Ratio of Tacrolimus | |
| No-Rejection | Patient undergone liver transplant wothout diagnosis of rejection within 10 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of early liver rejection
Evaluation of early liver rejection throught creation of a Tacrolimus blood-bile ratio
Measured: 10 days
Secondary outcomes (1)
Analysis of Tacrolimus toxicity
Evaluation of Tacrolimus toxicity throught blood dosage of the drug
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start21 Feb 2019
- Primary completionJul 2019 (estimated)
- Study completionMay 2020 (estimated)
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 Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marco Maria Pascale, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882164
- Sponsor's protocol ID
- PoliclinicoUAG-LTU
- Acronym
- BBRT
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 22 Mar 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pascale MM, Gervasoni J, Bianco G, Persichilli S, Ferri L, Primiano A, Agnes S, Urbani A. Graft bile analysis for predicting post-transplant outcomes: A literature review and a protocol for a novel biomarker. World J Gastrointest Surg. 2026 Jan 27;18(1):114662. doi: 10.4240/wjgs.v18.i1.114662.
PubMed 41695869
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tacrolimus Blood-bile Ratio for the Detection of Early Liver Failure After Liver Transplantation
- ClinicalTrials.gov ID
- NCT03882164
- Acronym / sponsor ID
- BBRT / PoliclinicoUAG-LTU
- Conditions
- Liver Transplant; Complications, Immunosuppression, Transplant Failure, Transplant; Complication, Rejection
- Keywords
- Liver transplant;, Immunosuppression;, Transplant rejection;
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 20 Mar 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.
Tacrolimus is the most widely used immunosuppressive drug in the prevention of rejection after solid organ transplantation. Pharmacokinetic studies in healthy volunteers and in transplanted patients have shown that this molecule is rapidly absorbed after oral administration (maximum plasma concentration after 1-2 hours), is found in the circulation bound mainly to erythrocytes and, after being metabolized by CYP3A4, is eliminated through the bile. The importance of the tacrolimus blood dosage is now widely recognized for detecting the immunosuppressive capacity reached in the individual patient or the eventual overdose of the drug. In the use of Tacrolimus after Liver Transplantation, however, it is interesting to note that the biochemical pathway for metabolism and excretion of the drug is present in the transplanted organ, the main object of immunological and functional surveillance. The excretory capacity of Tacrolimus by the liver through the bile, therefore, could be a useful tool for recognizing the early liver failure from a functional point of view, before the onset of hepatoecrosis.
Detailed description
Prospective monocentric randomized study comparing two parallel groups:
liver transplanted patients with early (10 POD) organ rejection (experimental arm); liver transplanted patients without early (10 POD) organ rejection (control arm) Primary Objective: Evaluation of a correlation between the reduction of Tacrolimus biliary excretion and the early liver failure Primary Endpoint: Increase of Tacrolimus blood-bile ratio measured before the onset of laboratory hepatonecrosis Secondary Objective: Analysis of the cause of any drug-related toxicity Secondary Endpoint: correlation study between drug dosage and biliary excretion level in case of blood overdose or clinical evidence of pharmacological toxicity
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rejection | – | Diagnostic Test: Blood-Bile Ratio of TacrolimusPatient undergone liver transplant with diagnosis of rejection within 10 days |
| No-Rejection | – | –Patient undergone liver transplant wothout diagnosis of rejection within 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergone liver transplant with positioning of Kehr tube
Key inclusion criteria (5 listed)
- Age ≥18 years
- History of recent liver transplant (less than 10 days)
- Placement of kehr tube in the biliary tract during liver transplant
- Immunosuppressive therapy with Tacrolimus
- Functioning of kehr tube
Key exclusion criteria (9 listed)
- Age - Age ≥18 years
- History of liver transplant for more than 10 days
- Liver transplant without positioning of kehr tube
- Immunosuppressive therapy with a drug different from Tacrolimus
- No functioning of kehr tube18 years
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 |
|---|---|---|
| Blood-Bile Ratio of TacrolimusDiagnosis of early transplanted liver dysfunction to adjust Tacrolimus dose adminstered | Diagnostic test | Rejection |
Primary outcome
Analysis of early liver rejection
Time frame: 10 days
Evaluation of early liver rejection throught creation of a Tacrolimus blood-bile ratio
1 secondary outcome
Analysis of Tacrolimus toxicity
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Derived from this study: PubMed 41695869Pascale MM, Gervasoni J, Bianco G, Persichilli S, Ferri L, Primiano A, Agnes S, Urbani A. Graft bile analysis for predicting post-transplant outcomes: A literature review and a protocol for a novel biomarker. World J Gastrointest Surg. 2026 Jan 27;18(1):114662. doi: 10.4240/wjgs.v18.i1.114662.
- Individual participant dataSharing planned: No
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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 Transplant; Complications and Immunosuppression, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 5 inclusion and 9 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 22 Mar 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 Italy. 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?
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?
Analysis of early liver rejection (time frame: 10 days). 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 NCT03882164, 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 22 Mar 2019.