Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203671
Status:
COMPLETED
Last Update Posted:
2010-07-13
First Post:
2005-09-12
Brief Title:
Mycophenolate Mofetil MMF A Long-Term Data Evaluation
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Mycophenolate Mofetil MMF A Long-Term Data Evaluation
Status:
COMPLETED
Status Verified Date:
2007-05
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 purposes of this study are
To review past clinical use of mycophenolate mofetil MMF in kidney transplant patients
To discover why doses were modified and how those modifications affected the survival and health of the transplanted kidney and
To determine whether therefore the side effects of MMF that result in dose alterations are related to outcome
To review past clinical use of mycophenolate mofetil MMF in kidney transplant patients
To discover why doses were modified and how those modifications affected the survival and health of the transplanted kidney and
To determine whether therefore the side effects of MMF that result in dose alterations are related to outcome
Detailed Description:
Objectives
We propose collecting data on the MMF total daily dose and regimens used in our transplant population from 1995 to 2003 We will assess why doses were modified and how those modifications affected graft survival and whether therefore the side effects of MMF that result in dose alterations are related to outcome
Implementation
1 Phase I - To describe initial MMF dosing and subsequent changes
2 Phase II - To explore the potential effect of the above on graft outcomes
3 Phase III - To explore reasons for dose changes and how these relate to tolerability
PHASE I
1 The initial maintenance total daily dose of mycophenolate mofetil MMF Cellcept Frequency distribution of initial maintenance total daily dose in mgday
Include subgroup information about
1 Cadaveric donors vs living donors
2 Regimen BID vs TID vs QID
3 Race AA vs Others
2 Changes in MMF dose from Initial Maintenance Dose censor patient info at time of rejection or graft loss
1 To answer this question we will look at all time points captured within the first post-transplant year or at 1 3 6 9 and 12 months post-transplant whichever is fewer
2 We will analyze the frequency distribution of daily doses and subgroup by cadaveric donor vs living donor sub-group
3 Patients that had no change in MMF total daily dose during their first year post-transplant
No dose change is defined as the same MMF dose at all time periods
4 Patients that had MMF permanently discontinued in their first year post-transplant
5 Patients that had a dose reduction during their first post-transplant year
6 Patients that had the frequency of their MMF daily regimen increased ie from BID to TID or QID during their first post-transplant year
PHASE II
1 Acute Rejection
1 Using the data from Statement 2A above we will assess how many patients experienced a treated acute rejection and stratify by dose into total-daily-dose groups as warranted by frequency distribution
2 Using the data from Statement 2 B C D above we will analyze whether MMF discontinuation dose reduction or increase in MMF dosing frequency is associated with the incidence of subsequent acute rejection
2 Graft failure
1 Using the data from Statement 2A above we will document how many patients had graft failure
2 Using the data from Statement 2 B C D above we will analyze whether MMF discontinuation MMF dose reduction or increase in MMF dosing frequency affects the incidence of graft failure
PHASE III
1 Reasons for Dose Reduction
The side effects that resulted in dose reduction will be documented and the effect of dose reduction in the subsequent period analyzed as above
We propose collecting data on the MMF total daily dose and regimens used in our transplant population from 1995 to 2003 We will assess why doses were modified and how those modifications affected graft survival and whether therefore the side effects of MMF that result in dose alterations are related to outcome
Implementation
1 Phase I - To describe initial MMF dosing and subsequent changes
2 Phase II - To explore the potential effect of the above on graft outcomes
3 Phase III - To explore reasons for dose changes and how these relate to tolerability
PHASE I
1 The initial maintenance total daily dose of mycophenolate mofetil MMF Cellcept Frequency distribution of initial maintenance total daily dose in mgday
Include subgroup information about
1 Cadaveric donors vs living donors
2 Regimen BID vs TID vs QID
3 Race AA vs Others
2 Changes in MMF dose from Initial Maintenance Dose censor patient info at time of rejection or graft loss
1 To answer this question we will look at all time points captured within the first post-transplant year or at 1 3 6 9 and 12 months post-transplant whichever is fewer
2 We will analyze the frequency distribution of daily doses and subgroup by cadaveric donor vs living donor sub-group
3 Patients that had no change in MMF total daily dose during their first year post-transplant
No dose change is defined as the same MMF dose at all time periods
4 Patients that had MMF permanently discontinued in their first year post-transplant
5 Patients that had a dose reduction during their first post-transplant year
6 Patients that had the frequency of their MMF daily regimen increased ie from BID to TID or QID during their first post-transplant year
PHASE II
1 Acute Rejection
1 Using the data from Statement 2A above we will assess how many patients experienced a treated acute rejection and stratify by dose into total-daily-dose groups as warranted by frequency distribution
2 Using the data from Statement 2 B C D above we will analyze whether MMF discontinuation dose reduction or increase in MMF dosing frequency is associated with the incidence of subsequent acute rejection
2 Graft failure
1 Using the data from Statement 2A above we will document how many patients had graft failure
2 Using the data from Statement 2 B C D above we will analyze whether MMF discontinuation MMF dose reduction or increase in MMF dosing frequency affects the incidence of graft failure
PHASE III
1 Reasons for Dose Reduction
The side effects that resulted in dose reduction will be documented and the effect of dose reduction in the subsequent period analyzed as above
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