Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression
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|ClinicalTrials.gov Identifier: NCT03800576|
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
|Condition or disease|
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|
|Estimated Enrollment :||113 participants|
|Official Title:||The Influence of Genetic and Clinical Factors on Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression|
|Estimated Study Start Date :||March 15, 2019|
|Estimated Primary Completion Date :||December 15, 2020|
|Estimated Study Completion Date :||December 15, 2020|
- Incidence of patients with biopsy proven acute rejection (BPAR) [ Time Frame: up to 12 months after liver transplantation ]Incidence of BPAR will be estimated with Kaplan-Meier analysis
- Graft survival [ Time Frame: up to 9 years after liver transplantation ]incidence of graft loss will be estimated Kaplan-Meier analysis
- Number of patients with tacrolimus-associated adverse events [ Time Frame: up to 9 years after liver transplantation ]
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
- Patient survival [ Time Frame: up to 9 years after liver transplantation ]incidence of death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800576
|Contact: Fe-Lin Lin Wuemail@example.com|
|National Taiwan University Hospital||Not yet recruiting|
|Contact: Rey-Heng Hu, professor +886-2-23934358 firstname.lastname@example.org|
|Principal Investigator:||Rey-Heng Hu, Professor||National Taiwan University Hospital|