The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03147157
• Other study ID #: LCPYJJ2017007
• Status: Not yet recruiting
• Phase: N/A
• First received: April 27, 2017
• Last updated: May 11, 2017
• Start date: May 2017
• Est. completion date: April 2025

Study information

• Verified date: May 2017
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.

Description:

Liver transplantation is the most effective treatment for end-stage liver disease, yet long term survival is limited by acute and chronic rejection reaction and adverse reactions caused by immune inhibitors. However, effective guideline of immune inhibitors regimen after liver transplantation is lacking. Human major histocompatibility antigens (HLA) is crucial in renal transplantation, while the role in liver transplantation is unclear. It is reported that HLA matching was closely related to the occurrence of graft versus host disease (GVHD) after liver transplantation. And by reducing or removing the immune inhibitors can change the course of illness, improve prognosis, at the same time conduce to induce immune tolerance. Therefore, the investigators have the reason to believe that HLA matching rate has closely association with postoperative immune status of patients after liver transplantation, which may guide immune inhibitors regimen. The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 2025
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients signed informed consent,patients with good compliance

Exclusion Criteria:

• autoimmune liver disease,ABO incompatibility,combined organ transplantation,re-transplantation

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Graft Rejection
• Graft Versus Host Disease
• Graft vs Host Disease
• Liver Transplantation

Intervention

Other:
• tacrolimus regimen guided by HLA matching rate
required low,middle and high tacrolimus concentration in high,middle and low MR group respectively

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Possibility of tacrolimus regimen guided by HLA matching rate	Changes of liver function and incidence of acute rejection early after liver transplantation	3 months
Secondary	Occurrence rate of GVHD	Occurrence rate of GVHD between the different groups	5 years
Secondary	Occurrence time of adverse reactions caused by immune inhibitors	Occurrence time of adverse reactions caused by immune inhibitors between the different groups	5 years
Secondary	Degree of adverse reactions caused by immune inhibitors	Degree of adverse reactions caused by immune inhibitors between the different groups	5 years
Secondary	Patient survival rate	Patient survival rate between the different groups	1-year,3-year and 5-year