Long-term Benefit of MPA in Liver Transplantation

Liver Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05707520
• Other study ID #: [2022]02-146-01
• Status: Recruiting
• Start date: December 4, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2023
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Yang Yang, PhD
• Phone: +8618922102666
• Email: yysysu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplant Rejection

Intervention

Drug:
• enteric-coated mycophenolate (MPAs)
Immunosuppression protocol with enteric-coated mycophenolate sodium
• None MPA
Immunosuppression protocol without enteric-coated mycophenolate sodium

Locations

Country	Name	City	State
China	Third Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (12)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University	Beijing Friendship Hospital, Beijing YouAn Hospital, Hebei Medical University Third Hospital, Huashan Hospital, People's Hospital of Guangxi, RenJi Hospital, Shulan (Hangzhou) 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, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complex endpoint	Graft loss or reoccurrence of HCC, or neoplasm, or death	60 months after liver transplantation
Secondary	Late onset acute rejection	rejection diagnosed by liver test, pathologic diagnosis by biopsy	60 months after liver transplantation
Secondary	Incidence of AKI or CKD	AKI/CKD diagnosed according to KDIGO 2012 AKI and CKD diagnosis criteria	60 months after liver transplantation
Secondary	Adverse events	Incidence of leukopenia/neutropenia, incidence of viral infections, incidence of new tumors (non-liver cancer).	60 months after liver transplantation