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

Kidney Transplantation Recipients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02356146
• Other study ID #: IRB225/56
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2015
• Last updated: February 1, 2015
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: February 2015
• Source: Chulalongkorn University
• Contact: Natavudh Townamchai, MD
• Phone: +66894904222
• Email: ntownamchai[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• All KT recipients

Exclusion Criteria:

• Recipient who not receiving tacrolimus

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation Recipients

Intervention

Drug:
• Tacrolimus C12

Locations

Country	Name	City	State
Thailand	Chulalongkorn University and King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target tacrolimus dose at 3 months		3 months	No
Secondary	rate of rejection		3-12 months	No
Secondary	rate of CNI toxicity		2-12 months	No