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

NCT00227045 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2007-04-20

No results posted yet for this study

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 \[S.R.\] ferrous sulfate)

Conditions

Sponsors & Collaborators

Principal Investigators

  • Jeong Park, PharmD · University of Michigan Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00227045 on ClinicalTrials.gov