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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Kidney Transplantation Recipients

NCT number NCT02356146
Study type Observational
Source Chulalongkorn University
Contact Natavudh Townamchai, MD
Phone +66894904222
Email ntownamchai@gmail.com
Status Recruiting
Phase N/A
Start date January 2012
Completion date June 2015

See also
  Status Clinical Trial Phase
Completed NCT01892761 - MPA Pharmacokinetics in Renal Transplantation N/A
Completed NCT02025335 - Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients N/A