Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187941
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
2005-09-13
Brief Title:
MPA PK Monitoring Strategy With MMFFK Based Immunosuppression
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pilot Trial for Implementation of a MedroxyprogesteroneMPAPharmacokineticPK Monitoring Strategy in Patients on Mycophenolate MofetilMMFFK Based Immunosuppression
Status:
COMPLETED
Status Verified Date:
2012-06
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:
Individuals absorb Cellcept MMFMycophenolate Mofetil at different rates and it is difficult to determine an individuals level of Mycophenolate Mofetil MMF trade name Cellceptfrom a single measurement We will enroll 20 subjects Plasma samples to be collected pre-MMF dose trough level and at 30 and 120 min after the morning dose of MMFThis will be done weekly for the first month and then monthly for the next 6 mths We hope to use a calculation of the subjects total MMF level during the first month to set a trough target level to use during the next 6 months
Detailed Description:
We would use repeated Areas-Under-the-Curve AUC-a statistical means of summarizing information from a series of measurements on one individual during the first month post transplant to establish a therapeutic drug exposure for each single patient We would use the individual trough level from each individual therapeutic AUC for a subsequent individual trough target range For the purpose of the study in order to show that by targeting these individualized Mycophenolic Acid MPA trough levels we effectively are keeping the patients within a therapeutic drug exposure range we would continue to obtain abbreviated AUCs at follow up visits The investigator would be blind to the results of these AUCs after the first month after transplant in order to allow drug exposure targeting only by trough measurements
From 4 days post transplant we would draw blood for abbreviated AUCs at 4-5 subsequent clinic visits within a 4 week time frame We would change the dose based on each AUC to establish an MPA target exposure above 30 mgL The individual trough level corresponding to the each patients AUC on target is going to be used for subsequent pk pharmacokinetic monitoring For example if a patient is on 1250 mg bid of Cellcept and we finally obtain an AUC of 40 mgLhr and the trough concentration at the time of this pk profile is 25 mgL we would subsequently target this patients trough level above 25 mgL The subsequent AUCs only needed for the study not for the final monitoring strategy once established would serve to confirm that by targeting the trough above 25 mgL the patient effectively stayed within the AUC target range of 30-60 mgL
The investigator would be blinded to the follow up AUCs after the first month because the primary objective of the study is to determine if by trough level targeting therapeutic exposure as measured by AUC can be achieved The investigators would not be blinded though to the initial AUCs which are used to get the patient initially into a therapeutic target window
We would not consider dose reductions based on elevated trough levels unless toxicities were present On the other hand we would act on low levels with dose increases in 250 mg bid increments
For this study we would propose 20 subjects to be enrolled Each patient would undergo abbreviated pk sampling 4-5 times between week 1 to 4 Subsequently we would do abbreviated AUCs monthly until month 7 We would enroll all patients including those presenting with slow graft function or delayed graft function except for those patients with early technical failure
Therefore for the study each patient would undergo approximately 12 abbreviated AUCs in the first 7 months post transplant Drop out patients will be replaced by new recruits to obtain an evaluable number of patients
From 4 days post transplant we would draw blood for abbreviated AUCs at 4-5 subsequent clinic visits within a 4 week time frame We would change the dose based on each AUC to establish an MPA target exposure above 30 mgL The individual trough level corresponding to the each patients AUC on target is going to be used for subsequent pk pharmacokinetic monitoring For example if a patient is on 1250 mg bid of Cellcept and we finally obtain an AUC of 40 mgLhr and the trough concentration at the time of this pk profile is 25 mgL we would subsequently target this patients trough level above 25 mgL The subsequent AUCs only needed for the study not for the final monitoring strategy once established would serve to confirm that by targeting the trough above 25 mgL the patient effectively stayed within the AUC target range of 30-60 mgL
The investigator would be blinded to the follow up AUCs after the first month because the primary objective of the study is to determine if by trough level targeting therapeutic exposure as measured by AUC can be achieved The investigators would not be blinded though to the initial AUCs which are used to get the patient initially into a therapeutic target window
We would not consider dose reductions based on elevated trough levels unless toxicities were present On the other hand we would act on low levels with dose increases in 250 mg bid increments
For this study we would propose 20 subjects to be enrolled Each patient would undergo abbreviated pk sampling 4-5 times between week 1 to 4 Subsequently we would do abbreviated AUCs monthly until month 7 We would enroll all patients including those presenting with slow graft function or delayed graft function except for those patients with early technical failure
Therefore for the study each patient would undergo approximately 12 abbreviated AUCs in the first 7 months post transplant Drop out patients will be replaced by new recruits to obtain an evaluable number of patients
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