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

The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplantation; Drug-Related Side Effects and Adverse Reactions; Graft Rejection; Graft Versus Host Disease
• Intervention / Treatment: Other: tacrolimus regimen guided by HLA matching rate

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients signed informed consent，patients with good compliance

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: research group,low MR group; tacrolimus regimen guided by HLA matching rate	Other: tacrolimus regimen guided by HLA matching rate; required low,middle and high tacrolimus concentration in high,middle and low MR group respectively
No Intervention: observation group,low MR group; tacrolimus regimen is applied according to clinical experience
Experimental: research group,middle MR group; tacrolimus regimen guided by HLA matching rate	Other: tacrolimus regimen guided by HLA matching rate; required low,middle and high tacrolimus concentration in high,middle and low MR group respectively
No Intervention: observation group,middle MR group; tacrolimus regimen is applied according to clinical experience
Experimental: research group,high MR group; tacrolimus regimen guided by HLA matching rate	Other: tacrolimus regimen guided by HLA matching rate; required low,middle and high tacrolimus concentration in high,middle and low MR group respectively
No Intervention: observation group,high MR group; tacrolimus regimen is applied according to clinical experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence rate of GVHD	Occurrence rate of GVHD between the different groups	5 years
Occurrence time of adverse reactions caused by immune inhibitors	Occurrence time of adverse reactions caused by immune inhibitors between the different groups	5 years
Degree of adverse reactions caused by immune inhibitors	Degree of adverse reactions caused by immune inhibitors between the different groups	5 years
Patient survival rate	Patient survival rate between the different groups	1-year,3-year and 5-year

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: May 6, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: tacrolimus; histocompatibility antigens
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Graft vs Host Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: LCPYJJ2017007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No