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NCT Number: NCT03800576

Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression

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.

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Key information

Conditions

Liver Transplantation

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. Graft survival

    Time frame: up to 9 years after liver transplantation

    incidence of graft loss will be estimated Kaplan-Meier analysis

Secondary outcomes

  1. 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

  2. Patient survival

    Time frame: up to 9 years after liver transplantation

    incidence of death

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 11, 2019
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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