Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients

Anemia Clinical Trial

Official title:

Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224003
• Other study ID #: FRO2001
• Secondary ID: FDA
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 18, 2009
• Start date: April 2003
• Est. completion date: February 2005

Study information

• Verified date: August 2009
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2005
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent.

• Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.

• Predetermined TSAT and serum Ferritin (at the screening visit).

• Receiving a stable EPO dosing regimen.

Exclusion Criteria:

• Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.

• Hypersensitivity to Ferrlecit or any of its inactive components.

• High TSAT level.

• High Serum Ferritin

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Sodium Ferric Gluconate Complex in Sucrose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Warady BA, Zobrist RH, Finan E; Ferrlecit Pediatric Study Group. Sodium ferric gluconate complex maintenance therapy in children on hemodialysis. Pediatr Nephrol. 2006 Apr;21(4):553-60. Epub 2006 Mar 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Ferritin		14 weeks	No
Primary	Transferrin Saturation		14 weeks	No
Secondary	Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.		14 weeks	Yes