Immunosuppressant Adverse Reaction, Liver Transplant Rejection
Conditions
Keywords
enteric-coated mycophenolate, adverse reaction, liver transplantation, transplant rejection
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.
Interventions
DRUGenteric-coated mycophenolate (MPAs)
Immunosuppression protocol with enteric-coated mycophenolate sodium
DRUGNone MPA
Immunosuppression protocol without enteric-coated mycophenolate sodium
Sponsors
Shulan (Hangzhou) Hospital
RenJi Hospital
The First Affiliated Hospital of Zhengzhou University
Beijing YouAn Hospital
Huashan Hospital
The Third Xiangya Hospital of Central South University
West China Hospital
Hebei Medical University Third Hospital
People's Hospital of Guangxi Zhuang Autonomous Region
Beijing Friendship Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complex endpoint | 60 months after liver transplantation | Graft loss or reoccurrence of HCC, or neoplasm, or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Contacts
Primary ContactYang Yang, PhD
Outcome results
None listed