Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression

Completed

• Conditions: Liver Transplantation

• Registration Number: NCT03800576
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-11
• Study Start: 2019-06-06
• Primary Completion: 2019-10-08
• Status Verified: 2020-01
• Study Completion: 2020-09-22
• Last Update Submitted: 2021-03-14
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of patients with biopsy proven acute rejection (BPAR)	up to 12 months after liver transplantation	Incidence of BPAR will be estimated with Kaplan-Meier analysis
Graft survival	up to 9 years after liver transplantation	incidence of graft loss will be estimated Kaplan-Meier analysis

Secondary Outcome Measures

Name	Time	Method
Patient survival	up to 9 years after liver transplantation	incidence of death
Number of patients with tacrolimus-associated adverse events	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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan