CellCept/Iron Study: The Iron Ion-Mycophenolate Mofetil Chelation Complex Interaction in Renal Allograft Recipients

Completed

Conditions studied: End Stage Renal Disease

In brief

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 \[S.R.\] ferrous sulfate)

Key facts

Study ID

NCT00227045

Run by

University of Michigan

People needed

20

Starts

2003-10-01

Last updated by the study team

2007-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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