Status:
COMPLETED
CellCept/Iron Study: The Iron Ion-Mycophenolate Mofetil Chelation Complex Interaction in Renal Allograft Recipients
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
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...
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 metabolit...
Eligibility Criteria
Inclusion
- Patients prescribed iron and mycophenolate mofetil concomitantly
- The subject must be able to give informed consent for the study.
- Stable renal transplant patients age 18 years and older.
- At least 6 months status-post primary or secondary kidney transplant.
- Stable organ function
- Patients who have achieved therapeutic levels of cyclosporine, tacrolimus, or sirolimus.
- Patients on stable doses of cyclosporine, tacrolimus, or sirolimus. Defined as: No dosage adjustments within 2 weeks prior to study entry.
- Patients receiving ferrous sulfate iron preparations (either sustained release or immediate release preparations) or polysaccharide iron complex
Exclusion
- Treated for acute rejection within the last 90 days
- Received other organ transplants in addition to kidney
- Pregnant or breast-feeding
- Use of iron supplements other than ferrous sulfate or polysaccharide iron complex
Key Trial Info
Start Date :
October 1 2003
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00227045
Start Date
October 1 2003
Last Update
April 20 2007
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109