Liver TransplantNCT06636409
Long-term Mortality Post Liver Transplantation in the Era of Modern Immunosuppression.
An observational study of Liver Transplant, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Liver transplantation is the primary intervention for decompensated chronic liver diseases and some cases of hepatocellular carcinoma. This study aims to examine long-term mortality after liver transplantation and identify related risk factors in the modern immunosuppression era, using a French multicenter cohort. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Collection of medical data
- How many people
- 1,343 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2023to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had liver transplant between 2008 and 2013
Who may be able to join
- Patients with liver transplant between 2008 and 2013 and follow up during 2008-2023
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Liver transplantation is the primary intervention for decompensated chronic liver diseases and some cases of hepatocellular carcinoma. This study aims to examine long-term mortality after liver transplantation and identify related risk factors in the modern immunosuppression era, using a French multicenter cohort. This study does not interfere with patients' medical care. The study method involves collecting and analyzing only the essential data from patient records.
Read the detailed description
Liver transplantation stands as the gold standard for treating decompensated chronic liver diseases and select cases of hepatocellular carcinoma. Over time, post-transplant survival rates have shown consistent improvement, attributed to advancements in surgical techniques, refined immunosuppressive protocols, and enhanced comprehension of post-transplant complications. These developments have significantly mitigated the incidence of infectious, immunological, and neoplastic complications following transplantation.
Research indicates post-liver transplant survival rates of approximately 85% at one year, 68% at five years, and 50% at ten years. It is important to note that these statistics are based on patients transplanted in the 1990s, whose immunosuppression relied on a combination of cyclosporine, azathioprine, and corticosteroids.
The field of immunosuppression has undergone substantial evolution, with an expansion in therapeutic options. These include the gradual replacement of Cyclosporine A with Tacrolimus, and the introduction of interleukin-2 receptor inhibitors, mycophenolate mofetil, and mTOR inhibitors. These innovations facilitate more adaptable protocols, offering improved preservation of renal function and allowing for earlier discontinuation of corticosteroids. As a result, these new therapeutic options offer immunosuppression that is more tailored to each patient, with reduced long-term toxicity.
The primary objective of this study is to investigate long-term mortality rates following liver transplantation and to identify the various risk factors contributing to mortality in these patients, with a particular focus on the current era of immunosuppression techniques. This investigation will be conducted within the framework of a French multicentric cohort study.
The results of this study have the potential to enhance our understanding of long-term post-transplant mortality and to more accurately identify risk factors. This knowledge could inform the refinement of immunosuppressive treatments and post-transplant patient care protocols. The overarching aim of this research is to optimize the management of liver transplant recipients and ultimately prolong their survival.
- Conditions
- Liver Transplant
- Being tested
- Collection of medical data
- Keywords
- Mortality, Risk factors, Decompensated chronic liver diseases, Survival, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of medical dataOther
A randomised selection of files to be analyzed will be conducted in each center to constitute a representative sample of liver transplanted patients. This represents 20% of the number of transplanted patients over the period 2008-2013 in the center, allowing a more in-depth analysis of the patients' medical records.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant patients | Liver transplant patients from all French centers between 2008 and 2013 and followed up during the period 2008-2023. Receives: Other: Collection of medical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term mortality rates
Evaluation of overall mortality rates among liver transplant recipients, measured from the time of transplantation until the end of the follow-up period.
Measured: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Risk factors for mortality
Identification of pre- and post-transplant risk factors associated with long-term mortality in liver transplant recipients. Risk factors include demographics (age, sex), comorbidities (diabetes, hypertension, cardiovascular diseases), and transplant-specific factors (MELD score, graft function).
Measured: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Secondary outcomes (6)
Demographic analysis of transplant recipients
Analysis of the demographic characteristics (age, gender, BMI, lifestyle factors such as diabetes, cardiovascular diseases, dyslipidemia, tobacco/alcohol use) of transplant recipients between 2008 and 2013 to determine trends and associations with outcomes
Measured: Baseline demographic analysis at 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Factors influencing mortality rates
Investigation of specific factors contributing to mortality rates, such as pre-existing liver disease, metabolic conditions and immunosuppressive therapy, in liver transplant recipients
Measured: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Progression of mortality risk factors
Measurement of how mortality risk factors evolve over time after liver transplantation, focusing on conditions like diabetes, hypertension, renal dysfunction, cardiovascular diseases and graft complications
Measured: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Mortality rates
Assessment of mortality rates specifically at the 1-year and 5-year post-transplant milestones to evaluate early and mid-term survival outcomes.
Measured: 1 year and 5 years post-transplant
Liver transplant-specific risk factors
Determination of transplant-specific risk factors, including graft rejection, graft dysfunction, recurrence of primary liver disease, and the need for re-transplantation, associated with post-transplant mortality
Measured: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Non-hepatic risk factors for mortality
Assessment of non-hepatic risk factors associated with post-transplant mortality, encompassing metabolic conditions (such as obesity, hypertension, and diabetes), cardiovascular and renal complications, extra-hepatic malignancies, and infectious diseases
Measured: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Aug 2023
- Primary completion30 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 1,343 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdalena MESZAROS, MD, Principal investigator, Saint Eloi-Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636409
- Sponsor's protocol ID
- RECHMPL19_0432
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Watt KD, Pedersen RA, Kremers WK, Heimbach JK, Charlton MR. Evolution of causes and risk factors for mortality post-liver transplant: results of the NIDDK long-term follow-up study. Am J Transplant. 2010 Jun;10(6):1420-7. doi: 10.1111/j.1600-6143.2010.03126.x. Epub 2010 May 10.
PubMed 20486907Dopazo C, Bilbao I, Castells LL, Sapisochin G, Moreiras C, Campos-Varela I, Echeverri J, Caralt M, Lazaro JL, Charco R. Analysis of adult 20-year survivors after liver transplantation. Hepatol Int. 2015 Jul;9(3):461-70. doi: 10.1007/s12072-014-9577-x. Epub 2014 Sep 18.
PubMed 25788182Meszaros M, Ursic-Bedoya J, Coilly A, Francoz C, Duvoux C, Conti F, Faitot F, Houssel-Debry P, Hardwigsen J, Hilleret MN, Vanlemmens C, Elkrief L, Kamar N, Anty R, Abergel A, Perignon C, Chiche L, Debette-Gratien M, Antonini T, Antoine C, Dharancy S, Dumortier J, Pageaux GP, Artru F. Long-term outcomes and temporal trends following liver transplantation for chronic liver disease in the intensive care unit. JHEP Rep. 2026 Jan 8;8(4):101722. doi: 10.1016/j.jhepr.2025.101722. eCollection 2026 Apr.
PubMed 41810429
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Mortality Post Liver Transplantation in the Era of Modern Immunosuppression.
- ClinicalTrials.gov ID
- NCT06636409
- Acronym / sponsor ID
- RECHMPL19_0432
- Conditions
- Liver Transplant
- Keywords
- Mortality, Risk factors, Decompensated chronic liver diseases, Survival, Immunosuppression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,343 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 10 Oct 2024 (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.
Liver transplantation is the primary intervention for decompensated chronic liver diseases and some cases of hepatocellular carcinoma. This study aims to examine long-term mortality after liver transplantation and identify related risk factors in the modern immunosuppression era, using a French multicenter cohort. This study does not interfere with patients' medical care. The study method involves collecting and analyzing only the essential data from patient records.
Detailed description
Liver transplantation stands as the gold standard for treating decompensated chronic liver diseases and select cases of hepatocellular carcinoma. Over time, post-transplant survival rates have shown consistent improvement, attributed to advancements in surgical techniques, refined immunosuppressive protocols, and enhanced comprehension of post-transplant complications. These developments have significantly mitigated the incidence of infectious, immunological, and neoplastic complications following transplantation.
Research indicates post-liver transplant survival rates of approximately 85% at one year, 68% at five years, and 50% at ten years. It is important to note that these statistics are based on patients transplanted in the 1990s, whose immunosuppression relied on a combination of cyclosporine, azathioprine, and corticosteroids.
The field of immunosuppression has undergone substantial evolution, with an expansion in therapeutic options. These include the gradual replacement of Cyclosporine A with Tacrolimus, and the introduction of interleukin-2 receptor inhibitors, mycophenolate mofetil, and mTOR inhibitors. These innovations facilitate more adaptable protocols, offering improved preservation of renal function and allowing for earlier discontinuation of corticosteroids. As a result, these new therapeutic options offer immunosuppression that is more tailored to each patient, with reduced long-term toxicity.
The primary objective of this study is to investigate long-term mortality rates following liver transplantation and to identify the various risk factors contributing to mortality in these patients, with a particular focus on the current era of immunosuppression techniques. This investigation will be conducted within the framework of a French multicentric cohort study.
The results of this study have the potential to enhance our understanding of long-term post-transplant mortality and to more accurately identify risk factors. This knowledge could inform the refinement of immunosuppressive treatments and post-transplant patient care protocols. The overarching aim of this research is to optimize the management of liver transplant recipients and ultimately prolong their survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant patients | – | Other: Collection of medical dataLiver transplant patients from all French centers between 2008 and 2013 and followed up during the period 2008-2023. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had liver transplant between 2008 and 2013
Key inclusion criteria (1 listed)
- Patients with liver transplant between 2008 and 2013 and follow up during 2008-2023
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Collection of medical dataA randomised selection of files to be analyzed will be conducted in each center to constitute a representative sample of liver transplanted patients. This represents 20% of the number of transplanted patients over the period 2008-2013 in the center, allowing a more in-depth analysis of the patients' medical records. | Other | Liver transplant patients |
Primary outcome
Long-term mortality rates
Time frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Evaluation of overall mortality rates among liver transplant recipients, measured from the time of transplantation until the end of the follow-up period.
Risk factors for mortality
Time frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Identification of pre- and post-transplant risk factors associated with long-term mortality in liver transplant recipients. Risk factors include demographics (age, sex), comorbidities (diabetes, hypertension, cardiovascular diseases), and transplant-specific factors (MELD score, graft function).
6 secondary outcomes
Demographic analysis of transplant recipients
Time frame: Baseline demographic analysis at 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Factors influencing mortality rates
Time frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Progression of mortality risk factors
Time frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Mortality rates
Time frame: 1 year and 5 years post-transplant
Liver transplant-specific risk factors
Time frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Non-hepatic risk factors for mortality
Time frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Results publication: PubMed 20486907Watt KD, Pedersen RA, Kremers WK, Heimbach JK, Charlton MR. Evolution of causes and risk factors for mortality post-liver transplant: results of the NIDDK long-term follow-up study. Am J Transplant. 2010 Jun;10(6):1420-7. doi: 10.1111/j.1600-6143.2010.03126.x. Epub 2010 May 10.
- Results publication: PubMed 25788182Dopazo C, Bilbao I, Castells LL, Sapisochin G, Moreiras C, Campos-Varela I, Echeverri J, Caralt M, Lazaro JL, Charco R. Analysis of adult 20-year survivors after liver transplantation. Hepatol Int. 2015 Jul;9(3):461-70. doi: 10.1007/s12072-014-9577-x. Epub 2014 Sep 18.
- Derived from this study: PubMed 41810429Meszaros M, Ursic-Bedoya J, Coilly A, Francoz C, Duvoux C, Conti F, Faitot F, Houssel-Debry P, Hardwigsen J, Hilleret MN, Vanlemmens C, Elkrief L, Kamar N, Anty R, Abergel A, Perignon C, Chiche L, Debette-Gratien M, Antonini T, Antoine C, Dharancy S, Dumortier J, Pageaux GP, Artru F. Long-term outcomes and temporal trends following liver transplantation for chronic liver disease in the intensive care unit. JHEP Rep. 2026 Jan 8;8(4):101722. doi: 10.1016/j.jhepr.2025.101722. eCollection 2026 Apr.
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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.
Magdalena MESZAROS, MD principal investigator
Saint Eloi-Hospital, Montpellier
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, run by University Hospital, Montpellier 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Long-term mortality rates (time frame: 1 year, 5 years, and 10 years post-transplant, as well as at the last follow-up). The study lists 2 primary outcomes in all. 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 NCT06636409, which also lists 3 linked publications.
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 10 Oct 2024.