Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression

Liver Transplantation Clinical Trial

Official title:

The Influence of Genetic and Clinical Factors on Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03800576
• Other study ID #: 201812015RINC
• Status: Completed
• Start date: June 6, 2019
• Est. completion date: September 22, 2020

Study information

• Verified date: January 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: September 22, 2020
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Eligible patients were those who had signed informed consent for genetic study in our previous research projects.

Inclusion Criteria of the Previous Study:

• patients who underwent living-donor liver transplantation during January 2008 to December 2017

• at the age of 20-65

• with tacrolimus-based immunosuppression after liver transplant for at least 6 months.

Exclusion Criteria of the Previous Study :

• retransplantation

• multi-organ transplantation

• human immunodeficiency virus (HIV) positive.

Related Conditions & MeSH terms

• Liver Transplantation

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Graft survival	incidence of graft loss will be estimated Kaplan-Meier analysis	up to 9 years after liver transplantation
Secondary	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	up to 9 years after liver transplantation
Secondary	Patient survival	incidence of death	up to 9 years after liver transplantation