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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02707822
• Other study ID #: 201512005RINC
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2016
• Last updated: March 9, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2016
• Source: National Taiwan University Hospital
• Contact: Fe-Lin Lin Wu
• Phone: +886-2-3366 8784
• Email: flwu[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Kidney Transplantation
• Liver Transplantation

Intervention

Other:
• Clinical and genetic factors

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	Dose-normalized tacrolimus concentration		Within the first 6 months post-transplantation	No