Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411944
Status:
COMPLETED
Last Update Posted:
2006-12-15
First Post:
2006-12-13
Brief Title:
Long-Term Pharmacokinetics of Tacrolimus in Renal Recipients
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
Prospective Study of the Influence of CYP3A4CYP3A5 and MDR1 Gene Single Nucleotide Polymorphisms on Long-Term Tacrolimus Disposition in Renal Allograft Recipients a Five Year Follow-up Study Using Abbreviated Concentration-Time Measurements
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
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:
An evaluation of the effects of genetically determined variant metabolizing and transporting proteins involved in the disposition of the immunosuppressive drug tacrolimus in renal transplant recipients In a five year follow-up study tacrolimus dose-corrected exposure changes significantly and the effects of single nucleotide polymorphisms of the CYP3A4CYP3A5 and MDR1 genes on the latter is assessed in this study
Detailed Description:
A 5-year pharmacokinetic follow-up study in 95 renal allograft recipients assessing tacrolimus exposure using repeated abbreviated Area-Under-the-Concentration-time AUC curve measurements at regular time points after grafting The effects of the CYP3A51 CYP3A41B MDR1 G2677TA and C3435T single nucleotide polymorphisms on the evolution of tacrolimus disposition are studied over 5 years in order to clarify the interrelationship between CYP3A5 CYP3A4 and MDR1 genotypes time-dependent exposure and tacrolimus-related toxicity
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