NCT05707520

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

January 6, 2023

Last Update Submit

January 28, 2023

Conditions

Liver Transplant RejectionImmunosuppressant Adverse Reaction

Keywords

enteric-coated mycophenolateadverse reactionliver transplantationtransplant rejection

Outcome Measures

Primary Outcomes (1)

  • complex endpoint

    Graft loss or reoccurrence of HCC, or neoplasm, or death

    60 months after liver transplantation

Secondary Outcomes (3)

  • Late onset acute rejection

    60 months after liver transplantation

  • Incidence of AKI or CKD

    60 months after liver transplantation

  • Adverse events

    60 months after liver transplantation

Study Arms (2)

MPA

Immunosuppressant with enteric-coated mycophenolate sodium

Drug: enteric-coated mycophenolate (MPAs)

None MPA

Immunosuppressant without enteric-coated mycophenolate sodium

Drug: None MPA

Interventions

enteric-coated mycophenolate (MPAs)DRUG

Immunosuppression protocol with enteric-coated mycophenolate sodium

MPA
None MPADRUG

Immunosuppression protocol without enteric-coated mycophenolate sodium

None MPA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Central Study Contacts

Yang Yang, PhD

CONTACT

+8618922102666yysysu@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of third Affiliated Hospital, Sun Yat-Sen University

Study Record Dates

First Submitted

January 6, 2023

First Posted

February 1, 2023

Study Start

December 4, 2022

Primary Completion

June 30, 2023

Study Completion

September 30, 2023

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations

CN(1)