Long-term Benefit of MPA in Liver Transplantation

Recruiting

• Conditions: Liver Transplant Rejection; Immunosuppressant Adverse Reaction
• Interventions: Drug: enteric-coated mycophenolate (MPAs); Drug: None MPA

• Registration Number: NCT05707520
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-04
• Status Verified: 2023-01
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-28
• Last Update Submitted: 2023-01-28
• Study First Posted: 2023-02-01
• Last Update Posted: 2023-02-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MPA	enteric-coated mycophenolate (MPAs)	Immunosuppressant with enteric-coated mycophenolate sodium
None MPA	None MPA	Immunosuppressant without enteric-coated mycophenolate sodium

Primary Outcome Measures

Name	Time	Method
complex endpoint	60 months after liver transplantation	Graft loss or reoccurrence of HCC, or neoplasm, or death

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Third Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China