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

Watson Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00223964

FR01006

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59 participants in 2 patient groups

dose level 1

Experimental group

Description:

1.5 mg/kg

Treatment:

Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)

dose level 2

Experimental group

Description:

3 mg/kg

Treatment:

Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection)