Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227045
Status:
COMPLETED
Last Update Posted:
2007-04-20
First Post:
2005-09-23
Brief Title:
CellCeptIron Study The Iron Ion-Mycophenolate Mofetil Chelation Complex Interaction in Renal Allograft Recipients
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
The Iron Ion-Mycophenolate Mofetil Chelation Complex Interaction A Two Phase Pharmacokinetic Study in Renal Allograft Recipients at the University of Michigan Transplant Program
Status:
COMPLETED
Status Verified Date:
2007-04
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 objective of this study is to determine the extent and magnitude of the pharmacokinetic drug interaction between mycophenolate mofetil MFF under Css conditions in the presence of iron in renal transplant recipients
A two phase pharmacokinetic study will be conducted to determine the bioavailability of MMF under steady state Css conditions in the presence of two commonly prescribed iron formulations polysaccharide iron complex and sustained release ferrous sulfate in renal transplant recipients This study will evaluate valuable clinical information to help better guide the appropriate utilization of the following formulations and dosing strategies
1 Polysaccharide iron complex concomitant administration with MMF
2 Sustained release ferrous sulfate concomitant administration with MMF
3 Dose separation 2 hours between MMF and iron polysaccharide iron complex or sustained release SR ferrous sulfate
A two phase pharmacokinetic study will be conducted to determine the bioavailability of MMF under steady state Css conditions in the presence of two commonly prescribed iron formulations polysaccharide iron complex and sustained release ferrous sulfate in renal transplant recipients This study will evaluate valuable clinical information to help better guide the appropriate utilization of the following formulations and dosing strategies
1 Polysaccharide iron complex concomitant administration with MMF
2 Sustained release ferrous sulfate concomitant administration with MMF
3 Dose separation 2 hours between MMF and iron polysaccharide iron complex or sustained release SR ferrous sulfate
Detailed Description:
Following oral administration MMF is rapidly absorbed and is presystemically hydrolyzed to its active form MPA in the liver It is then metabolized by glucuronyl transferase to its inactive metabolite mycophenolic acid glucuronide MPAG MPA and MPAG also undergo a significant enterohepatic recirculation process which is thought to contribute to the secondary peaks in the serum concentrations
Pharmacokinetic studies in healthy volunteers have demonstrated the bioavailability to be 94 Previous studies have shown that many concomitantly administered medications including magnesium and aluminum containing antacids and cholestyramine significantly impair bioavailability and decrease serum MPA AUCs from 37 and 40 respectively
However of the potentially significant drug interactions involving MMF iron may have the most clinically significant consequences A large portion of the transplant population particularly renal allograft recipients experience anemia requiring iron supplementation A single dose pharmacokinetic study conducted in seven healthy volunteers evaluated the effect of concomitant iron delayed release preparation administration on the absorption of MMF This study reported a significant 897 decrease in AUC among patients receiving concomitant iron and MMF Although this study provides valuable information it fails to address several clinically pertinent questions for transplant clinicians including
1 the potential impact on steady state MPA kinetics in transplant patients
2 effect of immediate release iron preparation compared with sustained release iron product and
3 the effect of timing of the dose relative to administration of MMF
Pharmacokinetic studies in healthy volunteers have demonstrated the bioavailability to be 94 Previous studies have shown that many concomitantly administered medications including magnesium and aluminum containing antacids and cholestyramine significantly impair bioavailability and decrease serum MPA AUCs from 37 and 40 respectively
However of the potentially significant drug interactions involving MMF iron may have the most clinically significant consequences A large portion of the transplant population particularly renal allograft recipients experience anemia requiring iron supplementation A single dose pharmacokinetic study conducted in seven healthy volunteers evaluated the effect of concomitant iron delayed release preparation administration on the absorption of MMF This study reported a significant 897 decrease in AUC among patients receiving concomitant iron and MMF Although this study provides valuable information it fails to address several clinically pertinent questions for transplant clinicians including
1 the potential impact on steady state MPA kinetics in transplant patients
2 effect of immediate release iron preparation compared with sustained release iron product and
3 the effect of timing of the dose relative to administration of MMF
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