CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 89 enrolled
Drug / intervention
Sodium Ferric Gluconate Complex in Sucrose Injection +1 moredrug
Likely dose
Sodium Ferric Gluconate Complex in Sucrose (Ferrlecit®) 250 mg IV weekly for 4 weeks or ferrous sulfate 325 mg orally three times daily for 6 weeksAI-extracted
Key inclusion· 3
  • Moderate to severe anemia
  • Iron deficiency
  • Moderate to severe chronic kidney disease
Key exclusion· 4
  • Currently receiving dialysis
  • Known sensitivity to Ferrlecit® or any of its components
  • Currently receiving erythropoietic agent therapy
  • Clinically unstable

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

Search/NCT00224055
NCT00224055Phase 4Completed

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

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 Injection and Ferrous sulfate tablets for Anemia, Iron-Deficiency and Kidney Failure, Chronic. Completed, enrolled 89 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 not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartApr 1, 2003
Primary CompletionSep 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 20.8 years ago

Interventions

Sodium Ferric Gluconate Complex in Sucrose Injectiondrug

Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks

Ferrous sulfate tabletsdrug

ferrous sulfate, 325 mg oral, three times daily for 6 weeks