Experience

Venofer® landmark clinical studies

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Study Design/METHODS

Study F was a randomized, open-label, dose-ranging study for iron maintenance treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD on stable erythropoietin therapy. The study randomized patients to 1 of 3 doses of Venofer® (iron sucrose) injection, USP (0.5 mg/kg, 1.0 mg/kg or 2.0 mg/kg). The mean age was 13 years (range 2 to 20 years). More than 70% of patients in all 3 groups were 12 years of age or older. There were 84 males and 61 females. About 60% of patients underwent hemodialysis, and 25% underwent peritoneal dialysis in all 3 dose groups. At baseline, the mean hemoglobin was 12 g/dL, the mean TSAT was 33% and the mean ferritin was 300 ng/mL. Patients with HDD-CKD received Venofer once every other week for 6 doses. Patients with PDD-CKD or NDD-CKD received Venofer once every 4 weeks for 3 doses.

Results

Among 131 evaluable patients with stable erythropoietin dosing, the proportion of patients who maintained hemoglobin between 10.5 g/dL and 14.0 g/dL during the 12-week treatment period was 58.7%, 46.7% and 45.0% in the Venofer 0.5 mg/kg, 1.0 mg/kg and 2.0 mg/kg groups, respectively. A dose-response relationship was not demonstrated.

STUDY REFERENCE

1. Goldstein SL, Morris D, Warady, BA. Comparison of the safety and efficacy of 3 iron sucrose iron maintenance regimens in children, adolescents, and young adults with CKD: a randomized controlled trial. Am J Kidney Dis. 2012:1-10.