Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187915
Status:
COMPLETED
Last Update Posted:
2011-10-20
First Post:
2005-09-14
Brief Title:
Pilot Trial for Implementation of a MPA PK Monitoring Strategy
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pilot Trial for Implementation of a MPA PK Monitoring Strategy
Status:
COMPLETED
Status Verified Date:
2011-10
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:
MPA
Brief Summary:
This study is a prospective interventional trial of de novo renal transplant recipients aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling and subsequent MPA trough level monitoring to implement MPA PK monitoring in a clinically applicable fashion
Detailed Description:
Mycophenolate mofetil or MMF CellCept by Roche is the mofetil ester of mycophenolic acid MPA the active immunosuppressant
MMF significantly decreases the episodes of acute rejection in kidney transplant patients but as with any medication without adequate pharmacokinetic drug monitoring the issue of under or over immunosuppression arises For this reason the biggest challenge lies with establishing a feasible mean of MPA pharmacokinetic monitoring Thus far no study has shown that measuring MPA trough levels alone correlates with rejection unlike MPA Area Under the concentration time Curve AUC due to the large incidence of inter- and intra-patient variability
This is the first prospective blinded trial set up to analyze the correlation between individualized MPA AUC and trough levels of kidney transplant patients in hopes of establishing a more efficacious way of monitoring MPA MPA target trough levels that correspond to AUC greater than 30 mg x hL could then be utilized as maintenance measurements
MMF significantly decreases the episodes of acute rejection in kidney transplant patients but as with any medication without adequate pharmacokinetic drug monitoring the issue of under or over immunosuppression arises For this reason the biggest challenge lies with establishing a feasible mean of MPA pharmacokinetic monitoring Thus far no study has shown that measuring MPA trough levels alone correlates with rejection unlike MPA Area Under the concentration time Curve AUC due to the large incidence of inter- and intra-patient variability
This is the first prospective blinded trial set up to analyze the correlation between individualized MPA AUC and trough levels of kidney transplant patients in hopes of establishing a more efficacious way of monitoring MPA MPA target trough levels that correspond to AUC greater than 30 mg x hL could then be utilized as maintenance measurements
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20030499 | OTHER | Western Institutional Review Board | None |