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Completed

NCT Number: NCT00223964

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aruascalientes, Mexico

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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 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.

Treatment and study plan

Ferrlecit (sodium ferric gluconate complex in sucrose injection)

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

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.

Important dates

Study start
2003
Primary completion
2003
First posted
Sep 22, 2005
Registry last updated
Aug 14, 2012

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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