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Influence of Genetic Polymorphism of Donor on Tacrolimus Concentration in Liver Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03140462
Recruitment Status : Unknown
Verified March 2017 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 4, 2017
Last Update Posted : May 4, 2017
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
To study the influence of donor's ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on tacrolimus blood concentration in liver transplant recipients.

Condition or disease
Liver Transplantation

Detailed Description:
This study will start with a retrospective data analysis. The investigators will use the electronic databases of National Taiwan University Hospital to identify patients who underwent liver transplantation, received tacrolimus and were still followed up at the outpatient clinic. Inclusion and exclusion criteria will be applied to screen appropriate participants, and find their donors. And analyze the effect of genetic polymorphism (ABCB1、CYP3A4、CYP3A5、POR) of donors, including other factors of recipients, on the dose normalized trough concentration of tacrolimus.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism of Donor on Tacrolimus Blood Concentration in Liver Transplant Patients
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

liver transplant patients and donors
To study clinical and genetic factors on tacrolimus dose normalized trough concentration.

Primary Outcome Measures :
  1. Dose normalized trough concentration of tacrolimus in liver transplant patients within the first 6 months post-transplantation [ Time Frame: Within the first 6 months post-transplantation ]
    Analyse the effect of the donor's genetic polymorphism to dose normalized trough concentration of tacrolimus in liver transplant patients. Trough level of tacrolimus was adjusted by liver recipient's body weight.

Biospecimen Retention:   Samples With DNA
whole blood , paraffin-embedded liver biopsy, or saliva

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:   Non-Probability Sample
Study Population
liver transplant patients' donors

Inclusion Criteria:donors' recipients

  • Living liver transplant during 20070101 ~ 20151231 and only received liver transplantation
  • Lab data at least 8 months,
  • Receiving tacrolimus as immunosuppressive drugs
  • Transplantation at 20 ~ 65 years old

Exclusion Criteria: donors' recipients

  • Retransplantation or multi-organ transplantation
  • Non-Asian
  • Positive for human immunodeficiency virus.

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 identifier (NCT number): NCT03140462

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Contact: Fe-Lin Lin Wu +886-2-3366 8784

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National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan
Contact: Rey-Heng Hu         
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Rey-Heng Hu National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital Identifier: NCT03140462     History of Changes
Other Study ID Numbers: 201612023RIND
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by National Taiwan University Hospital:
Genetic polymorphisms

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