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Safety and Efficacy of Iron Sucrose in Children

NCT00239642 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2021-11-17

Study results available
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Summary

Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients

Conditions

Interventions

DRUG

Venofer (iron sucrose injection)

0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

DRUG

Venofer (iron sucrose injection)

1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

DRUG

Venofer (iron sucrose injection)

2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Sponsors & Collaborators

  • American Regent, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark A Falone, MD · American Regent, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2009-01-31
Completion
2010-04-30

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 NCT00239642 on ClinicalTrials.gov