Single TransplantNCT05808192
De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal
An observational study of Single Transplant and 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Evaluate de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those taking immunosuppressive therapy ("non-tolerant"). Read more about this study
- Who is it for?
- Ages 49 to 89 years
- Conditions the study is for
- Single Transplant, 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS
- What is being tested?
- Immunosuppressive
- How many people
- 92 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 1 May 2022
- 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 49 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 92 patients with liver transplantation who attempted to suspend/ achieve suspension of immunosuppressive therapy, in follow-up in Tor Vergata transplant center.
Who may be able to join
- single LT recipients with an attempt of IS withdrawal
- minimum 5 years follow-up
Who cannot join
- Liver transplant combined with other organs
- Presence of metabolic syndrome and/or NASH and/or NAFLD as an indication for liver transplantation
- Loss of patient to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those taking immunosuppressive therapy ("non-tolerant").
Read the detailed description
A retrospective single-center study was conducted aiming to define the incidence of de novo Metabolic Syndrome (MS) in patients who withdraw Immunosoppression (IS) drugs after Liver Transplant (Tolerant-group) compared to these who couldn't wean IS drugs(non-TOL-group).
- Conditions
- Single Transplant, 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS
- Being tested
- Immunosuppressive
- Keywords
- Metabolic Syndrome, Liver transplantation, Immunosoppression, Tolerance
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunosuppressiveDrug
compare MS development in patients who achieve to suspend IS drugs after LT and in those who could not suspend.
| Study group | Role | What they receive |
|---|---|---|
| tolerant | patients who withdraw IS drugs after LT Receives: Drug: Immunosuppressive | |
| non tolerant | patients who couldn't wean IS drugs Receives: Drug: Immunosuppressive |
What is being measured
The primary outcome is the main question the study is designed to answer.
relation between MS development and IS in LT recipients
Evaluate the de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those who could not withdraw IS ("non-tolerant").
Measured: 5 years
Secondary outcomes (1)
IS withdrawal in LT recipients
Evaluate the clinical course of patients undergoing discontinuation of immunosuppressive therapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Sep 2020
- Primary completion1 Feb 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single TransplantStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Angelico, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808192
- Sponsor's protocol ID
- R.S.123.20
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal
- ClinicalTrials.gov ID
- NCT05808192
- Acronym / sponsor ID
- R.S.123.20
- Conditions
- Single Transplant, 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS
- Keywords
- Metabolic Syndrome, Liver transplantation, Immunosoppression, Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 11 Apr 2023 (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.
Evaluate de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those taking immunosuppressive therapy ("non-tolerant").
Detailed description
A retrospective single-center study was conducted aiming to define the incidence of de novo Metabolic Syndrome (MS) in patients who withdraw Immunosoppression (IS) drugs after Liver Transplant (Tolerant-group) compared to these who couldn't wean IS drugs(non-TOL-group).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tolerant | – | Drug: Immunosuppressivepatients who withdraw IS drugs after LT |
| non tolerant | – | Drug: Immunosuppressivepatients who couldn't wean IS drugs |
Who may qualify
- Ages
- 49 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 92 patients with liver transplantation who attempted to suspend/ achieve suspension of immunosuppressive therapy, in follow-up in Tor Vergata transplant center.
Key inclusion criteria (2 listed)
- single LT recipients with an attempt of IS withdrawal
- minimum 5 years follow-up
Key exclusion criteria (3 listed)
- Liver transplant combined with other organs
- Presence of metabolic syndrome and/or NASH and/or NAFLD as an indication for liver transplantation
- Loss of patient to follow-up
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 |
|---|---|---|
| Immunosuppressivecompare MS development in patients who achieve to suspend IS drugs after LT and in those who could not suspend. | Drug | non tolerant, tolerant |
Primary outcome
relation between MS development and IS in LT recipients
Time frame: 5 years
Evaluate the de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those who could not withdraw IS ("non-tolerant").
1 secondary outcome
IS withdrawal in LT recipients
Time frame: 5 years
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 11 Apr 2023.
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 Single Transplant and 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS, run by University of Rome Tor Vergata 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 2 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: finished, as of the sponsor's last update on 11 Apr 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 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?
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?
relation between MS development and IS in LT recipients (time frame: 5 years). 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 11 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.