Simultaneous Liver-kidney TransplantationFUTILITYNCT06712537
Renal Futility Following Simultaneous Liver-Kidney Transplantation
An observational study of Simultaneous Liver-kidney Transplantation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Liver transplantation in France represents a currently significant transplantation activity with a steady increase in the number of transplanted patients, with 1,294 liver transplants according to the Biomedicine Agency in 2022 compared to 806 liver transplants in 2000. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Simultaneous Liver-kidney Transplantation
- How many people
- 452 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to 31 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects who underwent simultaneous liver-kidney transplantation between January 1, 2013, and December 31, 2022, in France
Who may be able to join
- adult patient
- having undergone simultaneous liver-kidney transplantation between January 1, 2013, and December 31, 2022
- in France
Who cannot join
- multi-organ transplant other than simultaneous liver-kidney transplantation
- liver or kidney transplant alone
- minor patient
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal Futility Following Simultaneous Liver-Kidney Transplantation: What Identified Risk Factors to Avoid It?
Liver transplantation in France represents a currently significant transplantation activity with a steady increase in the number of transplanted patients, with 1,294 liver transplants according to the Biomedicine Agency in 2022 compared to 806 liver transplants in 2000. 4% of these transplanted patients, or 54, underwent combined liver-kidney transplantation in 2022.
The indication for combined transplantation fits within several scenarios: patients indicated for liver transplantation with severe renal insufficiency as a comorbidity, which worsens the prognosis in the case of liver transplantation alone; patients with renal insufficiency indicated for kidney transplantation with decompensated liver disease as a comorbidity; and diseases affecting both organs in a combined and severe manner.
Read more
However, some American studies have highlighted the significant prevalence of kidney transplant failure during simultaneous liver-kidney transplantation, estimated at around 20% at 3 months post-transplant. This failure of renal function recovery after the double transplant is defined by the need for dialysis or the occurrence of death. This represents a major issue concerning the mortality and morbidity of patients who have undergone simultaneous liver-kidney transplantation.
The aim of this study is to identify the risk factors for failure of renal function recovery after combined liver-kidney transplantation, thus indicating the futility of the kidney transplant in this context of double transplantation.
The outcomes will be multiple. On one hand, we will identify the population most suitable to benefit from this intervention, which will improve recommendations on access to simultaneous liver-kidney transplantation. On the other hand, we will develop an optimized strategy for the use of available grafts, in order to better address the current organ shortage and the increasing number of patients waiting for transplants.
- Keywords
- Simultaneous liver-kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Renal allograft futility | This refers to the group meeting the primary outcome, which is the need for dialysis or occurrence of death at 3 months after simultaneous liver-kidney transplantation. This group defines the absence of renal function recovery post-transplant and thus renal graft failure, termed renal futility. | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal futility, defined as the need for dialysis (intermittent or continuous) or occurrence of death at 3 months after simultaneous liver-kidney transplantation
The primary outcome is met if the patient undergoes dialysis (continuous or intermittent) or is dead at 3 months after simultaneous liver-kidney transplantation. The outcome is not met if the patient required dialysis during the early stages of their transplant but no longer needs it and is not undergoing dialysis at 3 months. The criterion is not met if the patient dies after the 3-month period following simultaneous liver-kidney transplantation.
This outcome is collected from electronic medical records by designated and authorized personnel. These records are stored within the hospital departments where patients are being monitored.
Measured: The outcome is collected at 3 months following the simultaneous liver-kidney transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 May 2024
- Primary completion30 Sep 2024
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simultaneous Liver-kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712537
- Sponsor's protocol ID
- 24-5281
- Acronym
- FUTILITY
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 2 Dec 2024
- 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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Futility Following Simultaneous Liver-Kidney Transplantation: What Identified Risk Factors to Avoid It?
- ClinicalTrials.gov ID
- NCT06712537
- Acronym / sponsor ID
- FUTILITY / 24-5281
- Keywords
- Simultaneous liver-kidney transplantation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 2 Dec 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 in France represents a currently significant transplantation activity with a steady increase in the number of transplanted patients, with 1,294 liver transplants according to the Biomedicine Agency in 2022 compared to 806 liver transplants in 2000. 4% of these transplanted patients, or 54, underwent combined liver-kidney transplantation in 2022.
The indication for combined transplantation fits within several scenarios: patients indicated for liver transplantation with severe renal insufficiency as a comorbidity, which worsens the prognosis in the case of liver transplantation alone; patients with renal insufficiency indicated for kidney transplantation with decompensated liver disease as a comorbidity; and diseases affecting both organs in a combined and severe manner.
However, some American studies have highlighted the significant prevalence of kidney transplant failure during simultaneous liver-kidney transplantation, estimated at around 20% at 3 months post-transplant. This failure of renal function recovery after the double transplant is defined by the need for dialysis or the occurrence of death. This represents a major issue concerning the mortality and morbidity of patients who have undergone simultaneous liver-kidney transplantation.
The aim of this study is to identify the risk factors for failure of renal function recovery after combined liver-kidney transplantation, thus indicating the futility of the kidney transplant in this context of double transplantation.
The outcomes will be multiple. On one hand, we will identify the population most suitable to benefit from this intervention, which will improve recommendations on access to simultaneous liver-kidney transplantation. On the other hand, we will develop an optimized strategy for the use of available grafts, in order to better address the current organ shortage and the increasing number of patients waiting for transplants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal allograft futility | – | –This refers to the group meeting the primary outcome, which is the need for dialysis or occurrence of death at 3 months after simultaneous liver-kidney transplantation. This group defines the absence of renal function recovery post-transplant and thus renal graft failure, termed renal futility. |
| Control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects who underwent simultaneous liver-kidney transplantation between January 1, 2013, and December 31, 2022, in France
Key inclusion criteria (3 listed)
Key exclusion criteria (4 listed)
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
Renal futility, defined as the need for dialysis (intermittent or continuous) or occurrence of death at 3 months after simultaneous liver-kidney transplantation
Time frame: The outcome is collected at 3 months following the simultaneous liver-kidney transplantation.
The primary outcome is met if the patient undergoes dialysis (continuous or intermittent) or is dead at 3 months after simultaneous liver-kidney transplantation. The outcome is not met if the patient required dialysis during the early stages of their transplant but no longer needs it and is not undergoing dialysis at 3 months. The criterion is not met if the patient dies after the 3-month period following simultaneous liver-kidney transplantation. This outcome is collected from electronic medical records by designated and authorized personnel. These records are stored within the hospital departments where patients are being monitored.
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 2 Dec 2024.
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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 Simultaneous Liver-kidney Transplantation, run by Hospices Civils de Lyon 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 4 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 2 Dec 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?
Renal futility, defined as the need for dialysis (intermittent or continuous) or occurrence of death at 3 months after simultaneous liver-kidney transplantation (time frame: The outcome is collected at 3 months following the simultaneous liver-kidney transplantation.). 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 2 Dec 2024.