Ignite Creation Date:
2024-05-06 @ 3:42 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02356146
Status:
UNKNOWN
Last Update Posted:
2015-02-05
First Post:
2015-02-01
Brief Title:
First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction
Sponsor:
Chulalongkorn University
Organization:
Chulalongkorn University
Study Overview
Official Title:
First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction
Status:
UNKNOWN
Status Verified Date:
2015-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 01 mgkg of tacrolimus TacC12 orally administered in 51 new kidney transplant recipients Patients with CYP3A5 inhibitorinducer 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 ngmL were recorded
The genotyping TacC12 and target tacrolimus dosage have good correlations
Plasma tacrolimus trough level was measured at 12 hours after first dose of 01 mgkg of tacrolimus TacC12 orally administered in 51 new kidney transplant recipients Patients with CYP3A5 inhibitorinducer 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 ngmL were recorded
The genotyping TacC12 and target tacrolimus dosage have good correlations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None