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

Anemia Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223964
• Other study ID #: FR01006
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 10, 2012
• Start date: June 2003

Study information

• Verified date: August 2012
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Countries where clinical trial is conducted

United States,  Mexico,  Poland,  Russian Federation,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy.		2 weeks	No
Secondary	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	No