Conditions: Anemia Chronic Kidney Disease
Keywords: Iron Anemia CKD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 141
Healthy volunteers: no

Brief 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)

Arms:
arm 1: 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously arm 2: 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously arm 3: 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Interventions: intervention 1: Venofer (iron sucrose injection) intervention 2: Venofer (iron sucrose injection) intervention 3: Venofer (iron sucrose injection)
Intervention descriptions: intervention 1: 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously intervention 2: 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously intervention 3: 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Protocol document: