Long-term Benefit of MPA in Liver Transplantation

NCT ID: NCT05707520

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-04

Study Completion Date

2023-09-30

Brief Summary

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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

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Conditions

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Liver Transplant Rejection Immunosuppressant Adverse Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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MPA

Immunosuppressant with enteric-coated mycophenolate sodium

enteric-coated mycophenolate (MPAs)

Intervention Type DRUG

Immunosuppression protocol with enteric-coated mycophenolate sodium

None MPA

Immunosuppressant without enteric-coated mycophenolate sodium

None MPA

Intervention Type DRUG

Immunosuppression protocol without enteric-coated mycophenolate sodium

Interventions

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enteric-coated mycophenolate (MPAs)

Immunosuppression protocol with enteric-coated mycophenolate sodium

Intervention Type DRUG

None MPA

Immunosuppression protocol without enteric-coated mycophenolate sodium

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shulan (Hangzhou) Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Beijing YouAn Hospital

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Hebei Medical University Third Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Yang Yang

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Yang, PhD

Role: CONTACT

+8618922102666

Facility Contacts

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Yang Yang, PHD

Role: primary

Yingcai Zhang

Role: backup

Other Identifiers

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[2022]02-146-01

Identifier Type: -

Identifier Source: org_study_id

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