Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients

August 10, 2012 updated by: Watson Pharmaceuticals

Randomized Double-Blind Parallel Group MultiCenter Study of the Efficacy of Two Doses of Ferrlecit® in Treatment of Iron Deficiency in Pediatric Hemodialysis Patients Receiving Epoetin.

This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Aruascalientes, Mexico
      • Mexico City, Mexico
  • Poland
      • Bialystok, Poland
      • Gdansk, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Szczecin, Poland
      • Torum, Poland
      • Wroclaw, Poland
      • Zabrze, Poland
  • Russian Federation
      • Bashkortostan, Russian Federation
      • Moscow, Russian Federation
      • Saint Petersburg, Russian Federation
      • Tartarstan, Russian Federation
  • Serbia
      • Belgrade, Serbia
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Los Angeles, California, United States
      • San Diego, California, United States
      • Stanford, California, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Missouri
      • Kansas City, Missouri, United States
    • New York
      • Bronx, New York, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female pediatric end-stage renal disease (ESRD) patients.
  • Predetermined TSAT and serum ferritin levels
  • Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.
  • Receiving a stable epoetin (EPO) dosing regimen.

Exclusion Criteria:

  • Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing.
  • Blood transfusion.
  • Hypersensitivity to Ferrlecit®.
  • Significant inflammatory conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dose level 1
1.5 mg/kg
Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)
Experimental: dose level 2
3 mg/kg
Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy.
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients.
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: GARY HOEL, RPh, PhD, WATSON LPHARMACEUTICAL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

August 10, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR01006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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