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NCT00227045 · ClinicalTrials.gov registry record

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

A clinical trial of End Stage Renal Disease, sponsored by University of Michigan.

Completed
Registry status
20
Enrollment target
1
Study location

NCT00227045: Completed study of End Stage Renal Disease, sponsored by University of Michigan.

NCT00227045 is a study of End Stage Renal Disease that has completed, run by University of Michigan. The registered enrollment target is 20 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00227045, a study of End Stage Renal Disease, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
20 participants
Enrollment target
1
Study location

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 Studied

End Stage Renal Disease

Study Locations (1)

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2003-10
University of Michigan

1,327 total trials

What the finished NCT00227045 record still lists

NCT00227045 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (98% lower).

The record links to 1 condition, with End Stage Renal Disease appearing as the primary indexed condition, and to 0 interventions.

NCT00227045 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT00227045 about?

NCT00227045 is a clinical study titled "CellCept/Iron Study: The Iron Ion-Mycophenolate Mofetil Chelation Complex Interaction in Renal Allograft Recipients". 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 bioava...

What is the current status of trial NCT00227045?

This trial is currently completed. The enrollment target is 20 participants. The study started on 2003-10.

What conditions does trial NCT00227045 study?

This clinical trial studies the following conditions: End Stage Renal Disease.

Who is sponsoring clinical trial NCT00227045?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00227045 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for End Stage Renal Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00227045's enrollment target sits among peer trials

20 69th of 86 higher than 17 of 86 other End Stage Renal Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00227045, the US trial registry maintained by the National Library of Medicine. NCT00227045 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.