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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02356146
Enrollment
60
Registered
2015-02-05
Start date
2012-01-31
Completion date
2015-06-30
Last updated
2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation Recipients

Keywords

Kidney transplantation, genotype, tacrolimus, CYP3A5

Brief 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.

Interventions

DRUGTacrolimus C12

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All KT recipients

Exclusion criteria

* Recipient who not receiving tacrolimus

Design outcomes

Primary

MeasureTime frame
target tacrolimus dose at 3 months3 months

Secondary

MeasureTime frame
rate of rejection3-12 months
rate of CNI toxicity2-12 months

Countries

Thailand

Contacts

Primary ContactNatavudh Townamchai, MD
ntownamchai@gmail.com+66894904222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026