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First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction

NCT02356146 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2015-02-05

No results posted yet for this study

Summary

Tacrolimus dose highly varies among Asian kidney transplant recipients. This can be explained by variety of CYP3A5 expression. CYP3A5 genotyping is highly recommended for patients receiving tacrolimus. Here, we assessed the tacrolimus dose prediction by comparing CYP3A5 expression and tacrolimus dosage using tacrolimus concentration after single dose administration prior to kidney transplantation.

Plasma tacrolimus trough level was measured at 12 hours after first dose of 0.1 mg/kg of tacrolimus (TacC12), orally administered in 51 new kidney transplant recipients. Patients with CYP3A5 inhibitor/inducer co-medications were excluded. Genotyping for CYP3A5 expression were carried out by RT-PCR. The dosages of tacrolimus at post-operative day 7 and dosage which provided stable therapeutic levels in post-operative month 1 to 3 (C0 5-8 ng/mL) were recorded.

The genotyping, TacC12, and target tacrolimus dosage have good correlations.

Conditions

  • Kidney Transplantation Recipients

Interventions

DRUG

Tacrolimus C12

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Natavudh Townamchai, MD · Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • Thailand

Study Locations

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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 NCT02356146 on ClinicalTrials.gov