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Genetic polymorphism and numerous clinical factors could influence tacrolimus pharmacokinetics, which led to large inter-and intra-individual variability.Since its narrow therapeutic range,predicting therapeutic outcome and individualized dosage remains to be a challenge. The study's objective is to identify the genetic and clinical factors that can influence clinical outcome in liver transplant.
A great number of studies had found significant correlation between tacrolimus pharmacokinetics and gene polymorphism. However, previous studies on the correlation between genetic factors and clinical outcome were controversial. Furthermore, most studies focused on single genetic polymorphism and clinical outcome, and very limited studies took multiple genetic factors and clinical factors into account.
This is a retrospective study. Eligible patients were those who had signed informed consent for genetic study in previous research projects ( IRB approval number:201512005RINC and 201612023RIND ). The present study will collect laboratory data, concurrent medications, and therapeutic drug monitoring (TDM) data. Patient survival, graft survival, acute rejection and tacrolimus-associated adverse events will be assessed.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of patients with biopsy proven acute rejection (BPAR) | Incidence of BPAR will be estimated with Kaplan-Meier analysis | up to 12 months after liver transplantation |
| Graft survival | incidence of graft loss will be estimated Kaplan-Meier analysis | up to 9 years after liver transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with tacrolimus-associated adverse events | Common adverse events of tacrolimus such as nephrotoxicity, post-transplant diabetes mellitus, hypertension, infection, hyperlipidemia and malignancy.
|
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Eligible patients were those who had signed informed consent for genetic study in our previous research projects.
Inclusion Criteria of the Previous Study:
Exclusion Criteria of the Previous Study :
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Patients who underwent living donor liver transplantation (LDLT) during 2008 to 2017 in National Taiwan University Hospital and received tacrolimus-based immunosuppression.
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| Name | Affiliation | Role |
|---|---|---|
| Rey-Heng Hu, Professor | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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| up to 9 years after liver transplantation |
| Patient survival | incidence of death | up to 9 years after liver transplantation |