CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 146 enrolled
Drug / intervention
Sodium Ferric Gluconate Complex +2 moredrug
Likely dose
Sodium Ferric Gluconate Complex 125 mg weekly for 8 weeks or 250 mg weekly for 4 weeks (intravenous); or oral iron 325 mg ferrous sulfate three times daily for 8 weeksAI-extracted
Key inclusion· 4
  • ✓Age ≥18 years
  • ✓On maintenance peritoneal dialysis for ≥4 weeks
  • ✓Expected to remain on peritoneal dialysis for duration of study
  • ✓Predetermined low hemoglobin and transferrin saturation (TSAT) levels
Key exclusion· 5
  • ✕Predetermined elevated serum ferritin and/or TSAT levels
  • ✕Pregnancy or lactation
  • ✕Serious concomitant medical disorder incompatible with study participation
  • ✕Known hypersensitivity to Ferrlecit or its components

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

Search/NCT00223977
NCT00223977Phase 3Completed
CompareCT.gov

A Multi-center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.

Watson Pharmaceuticals·interventional·Posted Sep 22, 2005·Updated Jul 8, 2013

In Brief

A Phase 3 clinical trial evaluating Sodium Ferric Gluconate Complex and Oral Iron for Iron Deficiency Anemia. Completed, enrolled 146 participants across 43 sites in 8 countries.

Detailed Summary

This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anemia
CountriesBulgaria, Canada, Croatia, India, Mexico, Poland, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartDec 1, 2003
Primary CompletionNov 1, 2004
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 20.8 years ago

Interventions

Sodium Ferric Gluconate Complexdrug

125 mg weekly x 8 weeks

Sodium Ferric Gluconate Complexdrug

250 mg weekly x 4

Oral Irondrug

325 mg ferrous sulfate orally three times daily x 8 weeks