Safety and Efficacy of Iron Sucrose in Children

Completed · Phase 4

Conditions studied: Anemia, Chronic Kidney Disease

In brief

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

Key facts

Study ID

NCT00239642

Run by

American Regent, Inc.

People needed

141

Starts

2005-07-01

Expected to finish

2010-04-01

Last updated by the study team

2021-11-17

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Luitpold Pharmaceutials — Norristown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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