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OpenTrials
Completed

NCT Number: NCT00224003

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent.
  • Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
  • Predetermined TSAT and serum Ferritin (at the screening visit).
  • Receiving a stable EPO dosing regimen.

Exclusion criteria

  • Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
  • Hypersensitivity to Ferrlecit or any of its inactive components.
  • High TSAT level.
  • High Serum Ferritin

Treatment and study plan

Sodium Ferric Gluconate Complex in Sucrose.

Drug

Primary outcomes

  1. Serum Ferritin

    Time frame: 14 weeks

    Change from baseline to 2 weeks after last Fe dose

  2. Transferrin Saturation

    Time frame: 14 weeks

    Change from baseline to 2 weeks after last dose

Secondary outcomes

  1. Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.

    Time frame: 14 weeks

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Sep 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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