Long-term Benefit of MPA in Liver Transplantation

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05707520

Collaborator

Shulan (Hangzhou) Hospital (Other), RenJi Hospital (Other), The First Affiliated Hospital of Zhengzhou University (Other), Beijing YouAn Hospital (Other), Huashan Hospital (Other), The Third Xiangya Hospital of Central South University (Other), West China Hospital (Other), Hebei Medical University Third Hospital (Other), People's Hospital of Guangxi (Other), Beijing Friendship Hospital (Other), Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

500

Enrollment

Location

9.9

Anticipated Duration (Months)

50.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant Rejection Immunosuppressant Adverse Reaction	Drug: enteric-coated mycophenolate (MPAs) Drug: None MPA

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 4, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
MPA Immunosuppressant with enteric-coated mycophenolate sodium	Drug: enteric-coated mycophenolate (MPAs) Immunosuppression protocol with enteric-coated mycophenolate sodium
None MPA Immunosuppressant without enteric-coated mycophenolate sodium	Drug: None MPA Immunosuppression protocol without enteric-coated mycophenolate sodium

Arm

Intervention/Treatment

MPA

Immunosuppressant with enteric-coated mycophenolate sodium

Drug: enteric-coated mycophenolate (MPAs)

Immunosuppression protocol with enteric-coated mycophenolate sodium

None MPA

Immunosuppressant without enteric-coated mycophenolate sodium

Drug: None MPA

Immunosuppression protocol without enteric-coated mycophenolate sodium

Outcome Measures

Primary Outcome Measures

complex endpoint [60 months after liver transplantation]
Graft loss or reoccurrence of HCC, or neoplasm, or death

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Third Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong	China	510630

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yang Yang, Vice president of third Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT05707520

Other Study ID Numbers:

[2022]02-146-01

First Posted:

Feb 1, 2023

Last Update Posted:

Feb 1, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yang Yang, Vice president of third Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University

enteric-coated mycophenolate

adverse reaction

liver transplantation

transplant rejection

Additional relevant MeSH terms:

Mycophenolic Acid