Long-term Benefit of MPA in Liver Transplantation | NCT05707520

Studies
Long-term Benefit of MPA in Liver Transplantation

NCT05707520

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Feb 1, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Liver Transplant Rejection
Immunosuppressant Adverse Reaction

Interventions

enteric-coated mycophenolate (MPAs)
None MPA

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 4, 2022Actual

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Sep 30, 2023Estimated

First Submitted Date

Jan 6, 2023

First Submission Date that Met QC Criteria

Jan 28, 2023

First Posted Date

Feb 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2023

Last Update Posted Date

Feb 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yang Yang, Vice president of third Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

Third Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Name	Class
Shulan (Hangzhou) Hospital	OTHER
RenJi Hospital	OTHER
The First Affiliated Hospital of Zhengzhou University	OTHER
Beijing YouAn Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MPA		Immunosuppressant with enteric-coated mycophenolate sodium	Drug: enteric-coated mycophenolate (MPAs)
None MPA		Immunosuppressant without enteric-coated mycophenolate sodium	Drug: None MPA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
enteric-coated mycophenolate (MPAs)	Drug	Immunosuppression protocol with enteric-coated mycophenolate sodium	MPA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complex endpoint	Graft loss or reoccurrence of HCC, or neoplasm, or death	60 months after liver transplantation

Secondary Outcomes

Measure	Description	Time Frame
Late onset acute rejection	rejection diagnosed by liver test, pathologic diagnosis by biopsy	60 months after liver transplantation
Incidence of AKI or CKD	AKI/CKD diagnosed according to KDIGO 2012 AKI and CKD diagnosis criteria

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yang Yang, PhD	Contact	+8618922102666		yysysu@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Third Affiliated Hospital, Sun Yat-Sen University	Recruiting	Guangzhou	Guangdong	510630	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

individual participant data will be shared on ResMan, after completion and the consent from investigators and IRB

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided