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Impact of CYP3A5 Gene Polymorphisms on Tacrolimus Concentrations and Outcomes in Thai Transplant Recipients

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: NCT02377791
Recruitment Status : Unknown
Verified February 2015 by Mahidol University.
Recruitment status was:  Enrolling by invitation
First Posted : March 4, 2015
Last Update Posted : March 4, 2015
Astellas Pharma Inc
Information provided by (Responsible Party):
Mahidol University

Brief Summary:

Tacrolimus is a drug used commonly in kidney transplant patients to prevent graft rejection. Tacrolimus acts in a very narrow range in the blood for its optimum activity. If the levels are too high, there is a risk of kidney injury, whereas, if the levels are too low there is a higher risk of rejection and graft loss. Genetic differences in the gene coding for the enzyme cytochrome P450 (CYP3A5), which is responsible for breaking down active tacrolimus can contribute to variations in blood levels of tacrolimus among different individuals taking the same dose of the drug. Certain genetic types lead to low concentrations, whereas certain genetic types can lead to high levels. The proportion of individuals with different types of genetic variations differ among different ethnic populations. Limited data are available in Thai subjects or on the risk have having certain types of genetic variations on the risk of rejection.

This study aims to compare the effects of different types of CYP3A5 gene variations on Tacrolimus drug levels and risk of acute rejection in Thais.

Condition or disease Intervention/treatment
Kidney Transplant Genetic: SNP: CYP3A5 gene polymorphisms

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of CYP3A5 Genetic Polymorphisms on Tacrolimus Concentration and Transplant Outcomes During The Early Stage Post-Transplantation in Thai Kidney Transplant Recipients
Study Start Date : July 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Intervention Details:
  • Genetic: SNP: CYP3A5 gene polymorphisms
    Evaluate impact of CYP3A5*1/*1 vs CYP3A5*1/*3 or CYP3A5*3/*3

Primary Outcome Measures :
  1. Trough tacrolimus blood concentration to dose ratio [ Time Frame: 3 days after transplant ]

Secondary Outcome Measures :
  1. Proportion achieved the target trough blood concentration within the first week [ Time Frame: 7 days after transplant ]
  2. Acute rejection rate [ Time Frame: 3 months after transplant ]

Biospecimen Retention:   Samples With DNA
DNA for polymorphism CYP3A5

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Thai recipients who underwent kidney transplantation between January 2011 and December 2013 and were receiving two divided daily doses of tacrolimus in their initial regimen for prevention of allograft rejection

Inclusion Criteria:

  1. Kidney transplantation between January 2011 and December 2013
  2. Received two divided daily doses of tacrolimus in their initial regimen for prevention of allograft rejection
  3. Informed consent

Exclusion Criteria:

  1. multiple organ transplantation
  2. hyperacute rejection
  3. non-functioning graft,
  4. ABO incompatible kidney transplantation
  5. severe liver function or hypoalbuminemia (serum albumin <3 g/dl)
  6. severe gastrointestinal disorders that could interfere with their ability to absorb oral medications
  7. patients whose recorded data is incomplete;
  8. Receiving other medications that can significantly interfere with tacrolimus pharmacokinetics (except methylprednisolone and prednisolone)

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): NCT02377791

Sponsors and Collaborators
Mahidol University
Astellas Pharma Inc
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Study Chair: Chagriya Kitiyakara, MD Ramathibodi Hospital, Faculty of Medicine, Mahidol University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mahidol University Identifier: NCT02377791    
Other Study ID Numbers: Rama 07-57-16
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: February 2015
Keywords provided by Mahidol University:
Cytochrome P-450 CYP3A
Kidney transplant
Gene Polymorphism