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

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

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)

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