Drug-Related Side Effects and Adverse Reactions, Graft Rejection, Graft Versus Host Disease, Liver Transplantation
Conditions
Keywords
tacrolimus, histocompatibility antigens
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.
Interventions
OTHERtacrolimus regimen guided by HLA matching rate
required low,middle and high tacrolimus concentration in high,middle and low MR group respectively
Sponsors
The First Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patients signed informed consent，patients with good compliance
Exclusion criteria
* autoimmune liver disease,ABO incompatibility,combined organ transplantation,re-transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Possibility of tacrolimus regimen guided by HLA matching rate | 3 months | Changes of liver function and incidence of acute rejection early after liver transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence rate of GVHD | 5 years | Occurrence rate of GVHD between the different groups |
| Occurrence time of adverse reactions caused by immune inhibitors | 5 years | Occurrence time of adverse reactions caused by immune inhibitors between the different groups |
| Degree of adverse reactions caused by immune inhibitors | 5 years | Degree of adverse reactions caused by immune inhibitors between the different groups |
| Patient survival rate | 1-year,3-year and 5-year | Patient survival rate between the different groups |
Outcome results
None listed