Long-term Benefit of MPA in Liver Transplantation

Study Overview
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Brief Summary
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MPA drugs are antiproliferative immunosuppressants and are widely used in solid organ transplantation. MPA drugs do not affect the recipient's kidney function and do not cause metabolic abnormalities and other problems. Intestinal solvent-based MPA drugs are widely used in clinical practice by improving the dosage form, reducing the irritation of MPA to the mucosa of the digestive tract, improving the tolerability of patients and maintaining a sufficient amount of MPA. However, data on the use/long-term use of intestinal solvent-based MPAs in liver transplant recipients are lacking. The study aims to evaluate the long-term benefits of enteric-coated mycophenolic acid in liver transplant recipients.

Official Title
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Clinical Evaluation of the Long-term Benefit of Enteric-coated Mycophenolate (MPAs) After Liver Transplantation

Conditions
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Liver Transplant Rejection, Immunosuppressant Adverse Reaction

Intervention / Treatment
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* Drug: enteric-coated mycophenolate (MPAs)
* Drug: None MPA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent their first liver transplantation between January 1, 2016 and February 28, 2021; Recipient's survival time≥ 1 year; Age 18 65 years old; Patients with complete data and no loss to follow-up. Exclusion Criteria: use of other types of anti-metabolic immunosuppressants; Second liver transplantation for various reasons within 1 year after the first transplantation; Patients with serious underlying diseases, including heart disease, infection and renal insufficiency, combined with other malignant tumors.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MPA<br>Immunosuppressant with enteric-coated mycophenolate sodium | Drug: enteric-coated mycophenolate (MPAs)<br>* Immunosuppression protocol with enteric-coated mycophenolate sodium<br>|
| None MPA<br>Immunosuppressant without enteric-coated mycophenolate sodium | Drug: None MPA<br>* Immunosuppression protocol without enteric-coated mycophenolate sodium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complex endpoint | Graft loss or reoccurrence of HCC, or neoplasm, or death | 60 months after liver transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late onset acute rejection | rejection diagnosed by liver test, pathologic diagnosis by biopsy | 60 months after liver transplantation | 
| Incidence of AKI or CKD | AKI/CKD diagnosed according to KDIGO 2012 AKI and CKD diagnosis criteria | 60 months after liver transplantation | 
| Adverse events | Incidence of leukopenia/neutropenia, incidence of viral infections, incidence of new tumors (non-liver cancer). | 60 months after liver transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enteric-coated mycophenolate, adverse reaction, liver transplantation, transplant rejection