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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Liver Transplantation

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.


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Study Type : Observational
Estimated Enrollment : 113 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who underwent living donor liver transplantation (LDLT) during 2008 to 2017 in National Taiwan University Hospital and received tacrolimus-based immunosuppression.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Fe-Lin Lin Wu +886-2-33668784 flwu@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan
Contact: Rey-Heng Hu, professor    +886-2-23934358    rhhu@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Rey-Heng Hu, Professor National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03800576     History of Changes
Other Study ID Numbers: 201812015RINC
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
tacrolimus
liver transplant
gene polymorphism
immunosuppressant

Additional relevant MeSH terms:
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Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action