Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189150
Status:
COMPLETED
Last Update Posted:
2016-05-25
First Post:
2005-09-12
Brief Title:
Pharmacokinetics of Mmf and Valganciclovir
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Pharmacokinetics of Mycophenolate Mofetil Alone and in Combination With Valganciclovir in Renal and Heart Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2016-05
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:
The primary objective of this study is to determine whether a clinically significant PK drug interaction a 30 difference in the AUC of MPA exists between mycophenolate mofetil under steady state conditions and VGCV in renal and cardiac transplant recipients
This study will provide clinically relevant information to the transplant community It will more clearly delineate whether a clinically significant PK drug interaction exists between mycophenolate mofetil under steady-state conditionsand VGCV Given the established doseefficacy relationship of both MMF and VGCV this study will provide improved dosing guidelines and potentially avoid adverse outcomes due to empiric dosage adjustments
This study will provide clinically relevant information to the transplant community It will more clearly delineate whether a clinically significant PK drug interaction exists between mycophenolate mofetil under steady-state conditionsand VGCV Given the established doseefficacy relationship of both MMF and VGCV this study will provide improved dosing guidelines and potentially avoid adverse outcomes due to empiric dosage adjustments
Detailed Description:
Mycophenolate mofetil immunosuppressant MMF and valganciclovir antiviral VGCV are commonly administered together in transplant patients Following oral administration both MMF and VGCV are metabolized to active forms mycophenolic acid MPA and gancoclovir GCV respectively Both MPA and GCV are eliminated through kidney and renal excretion but there is no data on how MPA pharmacokinetic parameters are affected by GCV at steady state condition Both MPA and GCV can cause neutropenia and although unsubstantiated some clinicians have observed an increased occurrence of neutropenia when these agents are used in combination In the presence of neutropenia practitioners are often challenged when making decisions regarding whether the dosage of one or both agents should be reduced It would be useful to know whether the neutropenia is due to increased drug concentration or whether it is due to direct effects of these agents on the bone marrow
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