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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00223964

Enrollment

Registered

2005-09-22

Start date

2003-06-30

Completion date

Unknown

Last updated

2012-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Iron Deficiency, Anemia in Pediatric Hemodialysis

Brief summary

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.

Interventions

DRUGFerrlecit (sodium ferric gluconate complex in sucrose injection)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 16 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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.	48 hours

Countries

Mexico, Poland, Russia, Serbia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026