Safety and Efficacy of Iron Sucrose in Children

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

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