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Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients

NCT00224003 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2009-09-28

Study results available
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Summary

A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.

Conditions

Interventions

DRUG

Sodium Ferric Gluconate Complex in Sucrose.

Sponsors & Collaborators

  • Watson Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Gary Hoel, RPh, PhD · Watson Laboratories, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2004-03-31
Completion
2005-02-28

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 NCT00224003 on ClinicalTrials.gov