Impact of CYP3A5 Gene Polymorphisms on Tacrolimus Concentrations and Outcomes in Thai Transplant Recipients
Impact of CYP3A5 Genetic Polymorphisms on Tacrolimus Concentration and Transplant Outcomes During The Early Stage Post-Transplantation in Thai Kidney Transplant Recipients
1 other identifier
observational
170
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Jul 2014
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMarch 4, 2015
February 1, 2015
1.2 years
February 26, 2015
March 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trough tacrolimus blood concentration to dose ratio
3 days after transplant
Secondary Outcomes (2)
Proportion achieved the target trough blood concentration within the first week
7 days after transplant
Acute rejection rate
3 months after transplant
Interventions
Evaluate impact of CYP3A5\*1/\*1 vs CYP3A5\*1/\*3 or CYP3A5\*3/\*3
Eligibility Criteria
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
You may qualify if:
- Kidney transplantation between January 2011 and December 2013
- Received two divided daily doses of tacrolimus in their initial regimen for prevention of allograft rejection
- Informed consent
You may not qualify if:
- multiple organ transplantation
- hyperacute rejection
- non-functioning graft,
- ABO incompatible kidney transplantation
- severe liver function or hypoalbuminemia (serum albumin \<3 g/dl)
- severe gastrointestinal disorders that could interfere with their ability to absorb oral medications
- patients whose recorded data is incomplete;
- Receiving other medications that can significantly interfere with tacrolimus pharmacokinetics (except methylprednisolone and prednisolone)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mahidol Universitylead
- Astellas Pharma Inccollaborator
Related Publications (1)
Yaowakulpatana K, Vadcharavivad S, Ingsathit A, Areepium N, Kantachuvesiri S, Phakdeekitcharoen B, Sukasem C, Sra-Ium S, Sumethkul V, Kitiyakara C. Impact of CYP3A5 polymorphism on trough concentrations and outcomes of tacrolimus minimization during the early period after kidney transplantation. Eur J Clin Pharmacol. 2016 Mar;72(3):277-83. doi: 10.1007/s00228-015-1990-0. Epub 2015 Dec 4.
PMID: 26635230DERIVED
Biospecimen
DNA for polymorphism CYP3A5
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chagriya Kitiyakara, MD
Ramathibodi Hospital, Faculty of Medicine, Mahidol University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2015
First Posted
March 4, 2015
Study Start
July 1, 2014
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
March 4, 2015
Record last verified: 2015-02