Clinical trial
De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal
Name
R.S.123.20
Description
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").
Trial arms
Trial start
2020-09-01
Estimated PCD
2022-02-01
Trial end
2022-05-01
Status
Completed
Treatment
Immunosuppressive
compare MS development in patients who achieve to suspend IS drugs after LT and in those who could not suspend.
Arms:
non tolerant, tolerant
Size
92
Primary endpoint
relation between MS development and IS in LT recipients
5 years
Eligibility criteria
Inclusion Criteria:
* single LT recipients with an attempt of IS withdrawal
* minimum 5 years follow-up
Exclusion Criteria:
* 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 92, 'type': 'ACTUAL'}}
Updated at
2023-04-11
1 organization
1 product
3 indications
Organization
University of Rome Tor VergataProduct
ImmunosuppressiveIndication
Single TransplantIndication
5 years of follow-up after transplant