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

NCT02377791 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2015-03-04

No results posted yet for this study

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.

Conditions

  • Kidney Transplant

Interventions

GENETIC

SNP: CYP3A5 gene polymorphisms

Evaluate impact of CYP3A5\*1/\*1 vs CYP3A5\*1/\*3 or CYP3A5\*3/\*3

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Mahidol University

    lead OTHER

Principal Investigators

  • Chagriya Kitiyakara, MD · Ramathibodi Hospital, Faculty of Medicine, Mahidol University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-09-30
Completion
2015-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02377791 on ClinicalTrials.gov