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Safety and Efficacy of Iron Sucrose in Children | Clinical Trials | Clareo Health

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Safety and Efficacy of Iron Sucrose in Children

Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients

NCT00239642•American Regent, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)

Eligibility

Age

2 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients between 2 to 21 years of age
•Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months for ≥ 3 months
•Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) \<60
•Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL
•Ferritin ≤ 800 ng/mL
•Transferrin saturation (TSAT) ≥ 20% to ≤ 50%
•Received stable erythropoietin (EPO) regimen for ≥ 8 weeks prior to the qualifying screening visit

Exclusion Criteria

•Known hypersensitivity to iron sucrose
•Severe diseased of the liver, cardiovascular system, or hemopoietic system
•Serious infection requiring hospitalization
•Significant blood loss within the last 3 months
•Bleeding disorders
•Pregnancy / Lactation
•Actively being treated for asthma
•Hemoglobinopathy
•Receiving a myelosuppressive drug

Locations (1)

Luitpold Pharmaceutials

Norristown, Pennsylvania, United States

Key Dates

Start Date

July 1, 2005

Primary Completion Date

January 1, 2009

Completion Date

April 1, 2010

Last Updated

November 17, 2021

Enrollment

141

ACTUAL participants

Conditions

AnemiaChronic Kidney Disease

Interventions

Venofer (iron sucrose injection)

DRUG

Venofer (iron sucrose injection)

DRUG

Venofer (iron sucrose injection)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Safety and Efficacy of Iron Sucrose in Children

Inclusion Criteria

Exclusion Criteria

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