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.
Study Type
OBSERVATIONAL
Enrollment
113
National Taiwan University Hospital
Taipei, Taiwan
Incidence of patients with biopsy proven acute rejection (BPAR)
Incidence of BPAR will be estimated with Kaplan-Meier analysis
Time frame: up to 12 months after liver transplantation
Graft survival
incidence of graft loss will be estimated Kaplan-Meier analysis
Time frame: up to 9 years after liver transplantation
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. * nephrotoxicity：decreased renal function estimated by glomerular filtration rate(GFR) using MDRD 4-Variable Equation * Post-transplant diabetes mellitus：defined by diagnosis and the use of antihyperglycemic agents, laboratory data including blood sugar(mg/dL) and hemoglobin A1c (percentage) * hypertension：defined by diagnosis and the use of antihypertensive agents, laboratory data including blood pressure(mmHg) * infection：defined by diagnosis of infection and the use of antiinfective agents * Hyperlipidemia：defined by diagnosis and the use of lipid-lowering agents, laboratory data including LDL (mg/dL), HDL (mg/dL) and total cholesterol (mg/dL) * malignancy：incidence of cancer
Time frame: up to 9 years after liver transplantation
Patient survival
incidence of death
Time frame: up to 9 years after liver transplantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.