CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 182 enrolled
Drug / intervention
Venofer +1 moredrug
Likely dose
Venofer 500 mg IV infusion over 3.5-4 hours on Days 0 and 14, or 200 mg IV injections over 2-5 minutes on 5 occasions from Day 0 to Day 14; or Ferrous Sulfate 325 mg orally three times daily for 56 daysAI-extracted
Key inclusion· 3
  • ✓Hemoglobin ≤11.5 g/dL
  • ✓Renal anemia confirmed
  • ✓Stable dose or not receiving EPO
Key exclusion· 5
  • ✕IV iron received within last 6 months
  • ✕Chronic infection, malignancy, or major surgery within last month
  • ✕Blood transfusion within last 2 months
  • ✕Significant blood loss within last 3 months

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

Search/NCT00236977
NCT00236977Phase 3Completed
CompareCT.gov

Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

American Regent, Inc.·interventional·Posted Oct 12, 2005·Updated Oct 6, 2020

In Brief

A Phase 3 clinical trial evaluating Venofer and Ferrous Sulfate for Anemia. Completed, enrolled 182 participants across 1 site.

Detailed Summary

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Study Details

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

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2005
Enrollment StartAug 1, 2003
Primary CompletionOct 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.7 years ago

Interventions

Venoferdrug

iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.

Ferrous Sulfatedrug

oral iron tablets; 325 mg three times a day orally for 56 days