The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism and Other Factors on Tacrolimus Blood Concentration

NCT ID: NCT02707822

Last Updated: 2016-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of the study is to identify factors that may influence tacrolimus (TAC) pharmacokinetics, and the impact of gene polymorphism (ABCB1, CYP3A4, CYP3A5, POR) on pharmacokinetics of TAC in Taiwanese.

Detailed Description

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TAC is one of the most important immunosuppressive agents for organ transplantation. In some patients the dose and concentration of TAC are difficult to adjust because of its narrow therapeutic index and variable pharmacokinetics.

Many factors affect the pharmacokinetics of TAC. Literature suggests that ABCB1, CYP3A4, CYP3A5, POR gene polymorphisms may affect the pharmacokinetics of TAC. In addition, the distribution of TAC is affected by hematocrit and albumin concentrations. The pharmacokinetics of TAC may also be affected by total protein, total bilirubin, creatinine, AST, ALT, gender, age, drug interactions, and so on.

This study intends to analyze the influence of various factors, including drugs, on the pharmacokinetics of TAC.

Conditions

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Kidney Transplantation Liver Transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Groups

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kidney or liver transplantation

Renal or liver transplant recipients with tacrolimus as immunosuppressive drugs.

Clinical and genetic factors

Intervention Type OTHER

Interventions

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Clinical and genetic factors

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* kidney transplants or liver transplants
* 20 - 65 years old
* receiving tacrolimus as immunosuppressive drugs

Exclusion Criteria

* Human immunodeficiency virus-positive status
* Retransplantation or multiorgan transplantation
* non-Asian
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meng-Kun Tsai

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Fe-Lin Lin Wu

Role: CONTACT

+886-2-3366 8784

Facility Contacts

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Meng-Kun Tsai

Role: primary

+886-972651461

Other Identifiers

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201512005RINC

Identifier Type: -

Identifier Source: org_study_id

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