CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Sodium Ferric Gluconate Complex in Sucrose.drug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Pediatric patients aged 2 to <16 years with ESRD on chronic hemodialysis
  • ✓Legally authorized representative provided signed informed consent
  • ✓Stabilized on chronic hemodialysis with identified need for maintenance iron therapy
  • ✓Receiving stable EPO dosing regimen
Key exclusion· 4
  • ✕Any iron supplementation during the 2 weeks prior to first Ferrlecit dose
  • ✕Hypersensitivity to Ferrlecit or any of its inactive components
  • ✕High TSAT level
  • ✕High serum ferritin

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00224003
NCT00224003Phase 4Completed
CompareCT.gov

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

Watson Pharmaceuticals·interventional·Posted Sep 22, 2005·Updated Sep 28, 2009

In Brief

A Phase 4 clinical trial evaluating Sodium Ferric Gluconate Complex in Sucrose. for Anemia. Completed, enrolled 23 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartApr 1, 2003
Primary CompletionMar 1, 2004
Study CompletionFeb 1, 2005
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 20.8 years ago

Interventions

Sodium Ferric Gluconate Complex in Sucrose.drug