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Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia

NCT00704353 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 735

Last updated 2018-02-20

Study results available
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Summary

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent

Conditions

Interventions

DRUG

Ferric Carboxymaltose

15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.

DRUG

Standard Medical Care (SMC)

Per product label

Sponsors & Collaborators

  • American Regent, 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
2008-06-30
Primary Completion
2009-07-31
Completion
2011-03-31

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 NCT00704353 on ClinicalTrials.gov