NCT02356146

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

3.2 years

First QC Date

February 1, 2015

Last Update Submit

February 1, 2015

Conditions

Kidney Transplantation Recipients

Keywords

Kidney transplantationgenotypetacrolimusCYP3A5

Outcome Measures

Primary Outcomes (1)

  • target tacrolimus dose at 3 months

    3 months

Secondary Outcomes (2)

  • rate of rejection

    3-12 months

  • rate of CNI toxicity

    2-12 months

Study Arms (1)

All KT recipient

Drug: Tacrolimus C12

Interventions

Tacrolimus C12DRUG
All KT recipient

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All KT recipient who transplanted and will be transplanted in King Chulalongkorn Memorial Hospital from 2012-2015

You may qualify if:

  • All KT recipients

You may not qualify if:

  • Recipient who not receiving tacrolimus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University and King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood level for tacrolimus was took 12 hours after first dose.

Study Officials

  • Natavudh Townamchai, MD

    Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natavudh Townamchai, MD

CONTACT

+66894904222ntownamchai@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 1, 2015

First Posted

February 5, 2015

Study Start

January 1, 2012

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

TH(1)