Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166244
Status:
COMPLETED
Last Update Posted:
2009-02-12
First Post:
2005-09-09
Brief Title:
Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
An Open Prospective Randomised Controlled Multi-Center Study Comparing Fixed Dose vs Concentration Controlled Mycophenolate Mofetil Regimens for de Novo Patients Following Transplantation
Status:
COMPLETED
Status Verified Date:
2009-02
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:
Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure
Detailed Description:
For treatment with mycophenolate mofetil the contribution of TDM still has to be determined although circumstantial evidence suggests the measurement of mycophenolic acid plasma concentrations adds to patient management
A concerted effort to test the hypothesis that TDM will improve outcome in mycophenolate mofetil therapy in a prospective randomised trial is to be made if we want to have a solid base for the continued measurements of mycophenolic acid concentrations in the future This trial aims to demonstrate the added value of TDM for mycophenolic acid by comparing fixed dose treatment with concentration controlled mycophenolate mofetil treatment in kidney transplant recipients
A concerted effort to test the hypothesis that TDM will improve outcome in mycophenolate mofetil therapy in a prospective randomised trial is to be made if we want to have a solid base for the continued measurements of mycophenolic acid concentrations in the future This trial aims to demonstrate the added value of TDM for mycophenolic acid by comparing fixed dose treatment with concentration controlled mycophenolate mofetil treatment in kidney transplant recipients
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