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Iron Indices and Intravenous Ferumoxytol: Time to Steady State

NCT01148745 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-03-30

Study results available
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Summary

The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as well as to determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA) hemodialysis patients.

Conditions

Interventions

DRUG

ferumoxytol

510 milligram (mg) intravenous (IV) injection (30 mg/second (sec) over 17 seconds) after at least one hour of hemodialysis (HD), second 510 mg IV injection administered at next consecutive dialysis treatment (3-5 days after first injection)

Sponsors & Collaborators

  • Dialysis Clinic, Inc.

    lead INDUSTRY

Principal Investigators

  • Toros Kapoian, MD · DCI North Brunswick

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01148745 on ClinicalTrials.gov