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

W

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

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)

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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