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Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis

NCT01227616 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2022-04-21

Study results available
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Summary

The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.

Conditions

  • Iron Deficiency Anemia Treatment
  • Chronic Kidney Disease(CKD)

Interventions

DRUG

Ferumoxytol

IV Ferumoxytol

DRUG

Iron Sucrose

IV Iron Sucrose

Sponsors & Collaborators

  • AMAG Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-02-29
Completion
2017-02-28

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

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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 NCT01227616 on ClinicalTrials.gov