CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 224 enrolled
Drug / intervention
iron sucrose injection USP +1 moredrug
Likely dose
Iron sucrose injection USP (dose not specified in trial record)AI-extracted
Key inclusion· 6
  • ✓Histologically confirmed cancer diagnosis
  • ✓Hemoglobin ≤10 g/dL
  • ✓Ongoing or planned chemotherapy
  • ✓Body weight >50 kg
Key exclusion· 10
  • ✕Active infection
  • ✕Multivitamins containing iron within 1 week of entry
  • ✕IV iron products within 2 months of study entry
  • ✕Myelophthisic bone marrow involvement by tumor (except hematologic malignancy)

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

Search/NCT00236951
NCT00236951Phase 3Completed
CompareCT.gov

A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy

American Regent, Inc.·interventional·Posted Oct 12, 2005·Updated Feb 20, 2018

In Brief

A Phase 3 clinical trial evaluating iron sucrose injection USP and stable erythropoietin therapy for Anemia. Completed, enrolled 224 participants.

Detailed Summary

To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2005
Enrollment StartFeb 1, 2003
Primary CompletionOct 1, 2005
Study CompletionDec 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.7 years ago

Interventions

iron sucrose injection USPdrug

stable erythropoietin therapydrug