CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 141 enrolled
Drug / intervention
Venofer (iron sucrose injection) +2 moredrug
Likely dose
Venofer (iron sucrose) 0.5–2.0 mg/kg intravenously up to 100 mg maximumAI-extracted
Key inclusion· 7
  • ✓Age 2 to 21 years
  • ✓On stable hemodialysis or peritoneal dialysis for ≥3 months
  • ✓Non-dialysis dependent patients with GFR <60 mL/min/1.73m²
  • ✓Hemoglobin 11 to 13.5 g/dL
Key exclusion· 9
  • ✕Known hypersensitivity to iron sucrose
  • ✕Severe disease of liver, cardiovascular, or hematopoietic system
  • ✕Serious infection requiring hospitalization
  • ✕Significant blood loss within last 3 months

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

Search/NCT00239642
NCT00239642Phase 4Completed
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Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients

American Regent, Inc.·interventional·Posted Oct 17, 2005·Updated Nov 17, 2021

In Brief

A Phase 4 clinical trial evaluating Venofer (iron sucrose injection) for Anemia and Chronic Kidney Disease. Completed, enrolled 141 participants across 1 site.

Detailed Summary

Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Chronic Kidney Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2005
Enrollment StartJul 1, 2005
Primary CompletionJan 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.7 years ago

Interventions

Venofer (iron sucrose injection)drug

0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Venofer (iron sucrose injection)drug

1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Venofer (iron sucrose injection)drug

2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously