CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 121 enrolled
Drug / intervention
Venofer and stable erythropoietin (EPO) regimen +1 moredrug
Likely dose
Venofer 300 mg IV over 1.5 hours on Days 1 and 15, and 400 mg IV over 2.5 hours on Day 29AI-extracted
Key inclusion· 5
  • ✓Hemoglobin between 9.5 and 11.5 g/dL
  • ✓Serum ferritin ≤500 ng/mL
  • ✓Serum transferrin saturation (TSAT) ≤25%
  • ✓Stable EPO regimen for at least 8 weeks prior to randomization
Key exclusion· 9
  • ✕Known sensitivity or allergy to iron sucrose
  • ✕Concomitant severe liver or cardiovascular disease
  • ✕Pregnancy or lactation
  • ✕Inadequate dialysis

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

Search/NCT00236938
NCT00236938Phase 3Completed
CompareCT.gov

Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

American Regent, Inc.·interventional·Posted Oct 12, 2005·Updated May 19, 2021

In Brief

A Phase 3 clinical trial evaluating Venofer and stable erythropoietin (EPO) regimen and stable erythropoietin (EPO) regimen for Anemia. Completed, enrolled 121 participants.

Detailed Summary

This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

Study Details

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

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 12, 2005
Enrollment StartJul 1, 2002
Primary CompletionSep 1, 2004
Study CompletionOct 1, 2004
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 20.7 years ago

Interventions

Venofer and stable erythropoietin (EPO) regimendrug

Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.

stable erythropoietin (EPO) regimendrug

Stable erythropoietin (EPO) dose and no supplemental iron.