Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337493
Status:
COMPLETED
Last Update Posted:
2012-09-17
First Post:
2006-06-15
Brief Title:
Pharmacogenetic Study of CellCept Mycophenolate Mofetil in Kidney Transplant Patients
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Study to Investigate the Impact of Pharmacogenetics on CellCept Use in Patients Participating in a Study in Renal Transplantation
Status:
COMPLETED
Status Verified Date:
2012-09
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:
This study will determine which if any allelic variants of mycophenolic acid MPA metabolizing enzymes drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation and will have one additional blood sample taken during the study The anticipated time on study treatment in study ML17225 is 1-2 years and the target sample size is 500 individuals
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