CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
Sodium Ferric Gluconate complex in sucrose +1 moredrug
Likely dose
Sodium ferric gluconate complex in sucrose 250 mg IV weekly for 4 doses (experimental arm)AI-extracted
Key inclusion· 4
  • ✓Moderate to severe anemia
  • ✓Iron deficiency
  • ✓Moderate to severe chronic kidney disease
  • ✓Currently receiving erythropoietic agent therapy
Key exclusion· 3
  • ✕Currently receiving dialysis
  • ✕Known sensitivity to Ferrlecit or any of its components
  • ✕Clinically unstable

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

Search/NCT00224042
NCT00224042Phase 4Completed
CompareCT.gov

A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease Being Treated With Erythropoietic Therapy

Watson Pharmaceuticals·interventional·Posted Sep 22, 2005·Updated Mar 29, 2012

In Brief

A Phase 4 clinical trial evaluating Sodium Ferric Gluconate complex in sucrose and Ferrous sulfate tablets for Anemia, Iron-Deficiency and Kidney Failure, Chronic. Completed, enrolled 52 participants across 24 sites in 2 countries.

Detailed Summary

This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Iron-Deficiency, Kidney Failure, Chronic
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartApr 1, 2003
Primary CompletionMay 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.8 years ago

Interventions

Sodium Ferric Gluconate complex in sucrosedrug

Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses

Ferrous sulfate tabletsdrug

ferrous sulfate 325 mg three times daily for 6 weeks