Safety and Efficacy of Iron Sucrose in Children

American Regent

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Anemia

Treatments: Drug: Venofer (iron sucrose injection)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00239642

1VEN03017

Details and patient eligibility

About

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

Full 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)

Enrollment: 141 patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 3 patient groups

Venofer (0.5 mg/kg)

Experimental group

Description:

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

Treatment:

Drug: Venofer (iron sucrose injection)

Drug: Venofer (iron sucrose injection)

Drug: Venofer (iron sucrose injection)

Venofer (1.0 mg/kg)

Experimental group

Description:

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

Treatment:

Drug: Venofer (iron sucrose injection)

Drug: Venofer (iron sucrose injection)

Drug: Venofer (iron sucrose injection)

Venofer (2.0 mg/kg)

Experimental group

Description:

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

Treatment:

Drug: Venofer (iron sucrose injection)

Drug: Venofer (iron sucrose injection)

Drug: Venofer (iron sucrose injection)