Long-term Benefit of MPA in Liver Transplantation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Transplant Rejection; Immunosuppressant Adverse Reaction
• Intervention / Treatment: Drug: enteric-coated mycophenolate (MPAs); Drug: None MPA

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Yang Yang, PhD; Phone Number: +8618922102666; Email: yysysu@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • Third Affiliated Hospital, Sun Yat-Sen University
      • Sub-Investigator: Huimin Yi, MD
      • Sub-Investigator: Haijin Lv, MD
      • Sub-Investigator: Hui Zhao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Long-term survived liver transplant recipients in 13 hospitals in China

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 4, 2022
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 28, 2023
• First Posted (ACTUAL): February 1, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 28, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: liver transplantation; transplant rejection; adverse reaction; enteric-coated mycophenolate
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: [2022]02-146-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: individual participant data will be shared on ResMan, after completion and the consent from investigators and IRB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No