Back to resultsThe Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation
Primary Purpose
Liver Transplantation, Graft Versus Host Disease, Graft Rejection
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tacrolimus regimen guided by HLA matching rate
Sponsored by
About this trial
This is an interventional treatment trial for Liver Transplantation focused on measuring tacrolimus, histocompatibility antigens
Eligibility Criteria
Inclusion Criteria:
- patients signed informed consent，patients with good compliance
Exclusion Criteria:
- autoimmune liver disease,ABO incompatibility,combined organ transplantation,re-transplantation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Experimental
No Intervention
Arm Label
research group,low MR group
observation group,low MR group
research group,middle MR group
observation group,middle MR group
research group,high MR group
observation group,high MR group
Arm Description
tacrolimus regimen guided by HLA matching rate
tacrolimus regimen is applied according to clinical experience
tacrolimus regimen guided by HLA matching rate
tacrolimus regimen is applied according to clinical experience
tacrolimus regimen guided by HLA matching rate
tacrolimus regimen is applied according to clinical experience
Outcomes
Primary Outcome Measures
Possibility of tacrolimus regimen guided by HLA matching rate
Changes of liver function and incidence of acute rejection early after liver transplantation
Secondary Outcome Measures
Occurrence rate of GVHD
Occurrence rate of GVHD between the different groups
Occurrence time of adverse reactions caused by immune inhibitors
Occurrence time of adverse reactions caused by immune inhibitors between the different groups
Degree of adverse reactions caused by immune inhibitors
Degree of adverse reactions caused by immune inhibitors between the different groups
Patient survival rate
Patient survival rate between the different groups
Full Information
NCT ID
NCT03147157
First Posted
April 27, 2017
Last Updated
May 11, 2017
Sponsor
The First Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT03147157
Brief Title
The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation
Official Title
The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2017 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Hospital of Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Graft Versus Host Disease, Graft Rejection, Drug-Related Side Effects and Adverse Reactions
Keywords
tacrolimus, histocompatibility antigens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
research group,low MR group
Arm Type
Experimental
Arm Description
tacrolimus regimen guided by HLA matching rate
Arm Title
observation group,low MR group
Arm Type
No Intervention
Arm Description
tacrolimus regimen is applied according to clinical experience
Arm Title
research group,middle MR group
Arm Type
Experimental
Arm Description
tacrolimus regimen guided by HLA matching rate
Arm Title
observation group,middle MR group
Arm Type
No Intervention
Arm Description
tacrolimus regimen is applied according to clinical experience
Arm Title
research group,high MR group
Arm Type
Experimental
Arm Description
tacrolimus regimen guided by HLA matching rate
Arm Title
observation group,high MR group
Arm Type
No Intervention
Arm Description
tacrolimus regimen is applied according to clinical experience
Intervention Type
Other
Intervention Name(s)
tacrolimus regimen guided by HLA matching rate
Intervention Description
required low,middle and high tacrolimus concentration in high,middle and low MR group respectively
Primary Outcome Measure Information:
Title
Possibility of tacrolimus regimen guided by HLA matching rate
Description
Changes of liver function and incidence of acute rejection early after liver transplantation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Occurrence rate of GVHD
Description
Occurrence rate of GVHD between the different groups
Time Frame
5 years
Title
Occurrence time of adverse reactions caused by immune inhibitors
Description
Occurrence time of adverse reactions caused by immune inhibitors between the different groups
Time Frame
5 years
Title
Degree of adverse reactions caused by immune inhibitors
Description
Degree of adverse reactions caused by immune inhibitors between the different groups
Time Frame
5 years
Title
Patient survival rate
Description
Patient survival rate between the different groups
Time Frame
1-year,3-year and 5-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients signed informed consent，patients with good compliance
Exclusion Criteria:
autoimmune liver disease,ABO incompatibility,combined organ transplantation,re-transplantation
12. IPD Sharing Statement
Learn more about this trial
The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation
We'll reach out to this number within 24 hrs