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

Watson Pharmaceuticals59 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Anemia

Interventions

Ferrlecit (sodium ferric gluconate complex in sucrose injection)DRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (24)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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