First Tacrolimus Dose Trough Level is Better Than CYP3A5... | NCT02356146

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

NCT02356146

Sponsor

Chulalongkorn University

Status

Unknown status

Last Update Posted

Feb 5, 2015Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Kidney Transplantation Recipients

Interventions

Tacrolimus C12

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Apr 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Feb 1, 2015

First Submission Date that Met QC Criteria

Feb 1, 2015

First Posted Date

Feb 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2015

Last Update Posted Date

Feb 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Natavudh Townamchai, MD, Assistant Professor, Chulalongkorn UniversityPrincipal Investigator

Lead Sponsor

Chulalongkorn UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Label	Type	Description	Intervention Names
All KT recipient			Drug: Tacrolimus C12

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus C12	Drug		All KT recipient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
target tacrolimus dose at 3 months		3 months

Secondary Outcomes

Measure	Description	Time Frame
rate of rejection		3-12 months
rate of CNI toxicity		2-12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All KT recipients

Exclusion Criteria:

Recipient who not receiving tacrolimus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Natavudh Townamchai, MD	Contact	+66894904222		ntownamchai@gmail.com

Overall Officials

Name	Affiliation	Role
Natavudh Townamchai, MD	Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chulalongkorn University and King Chulalongkorn Memorial Hospital	Recruiting	Bangkok		10330	Thailand