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Single-Dosage Pharmacokinetics of Sodium Ferric Gluconate Complex in Iron-Deficient Pediatric Hemodialysis Patients

Bradley A. Warady^*, Paul A. Seligman, and Naomi V. Dahl

^* Department of Pediatrics, Section of Pediatric Nephrology, Children's Mercy Hospital, Kansas City, Missouri; Department of Medicine, Division of Hematology, University of Colorado School of Medicine, Denver, Colorado; and Watson Laboratories, Morristown, New Jersey

Correspondence: Dr. Bradley A. Warady, Children's Mercy Hospital, 2401 Gillham Road, Kansas City, MO 64108. Phone: 816-234-3010; Fax: 816-234-3494; E-mail: bwarady{at}cmh.edu

Background and objectives: The clinical use of sodium ferric gluconate complex in iron-deficient pediatric patients receiving hemodialysis was recently approved. This study was designed to describe the pharmacokinetic parameters of the medication.

Design, setting, participants, & measurements: Iron-deficient pediatric (15 yr) hemodialysis patients were randomly assigned to two doses (1.5 and 3.0 mg/kg) of sodium ferric gluconate complex. Blood samples taken during a 1-h infusion and at multiple intervals during 48 h were analyzed for total iron, transferrin-bound iron, and sodium ferric gluconate complex–bound iron.

Results: Forty-nine patients (mean age 12.3 ± 2.5 yr) participated in the study. Mean serum iron concentrations rapidly increased in a dosage-dependent manner. A rapid rise in total serum iron was followed by a slower, less prominent rise in transferrin-bound iron. This was qualitatively confirmed by visualization of the transferrin bands from polyacrylamide gel electrophoresis. Single-dose pharmacokinetics of sodium ferric gluconate complex–bound iron was described using noncompartmental analytical methods. Mean values for the 1.5 mg/Kg dose were as follows: t_1/2 2.0 ± 0.7 h, C_max 1287 mcg/dl, T_max 1.1 ± 0.23 h, Cl 0.69 ± 0.50 L/h, Vd 1.6 ± 0.6 L, AUC_0-. 9499 ± 4089 mcg · hr/dl.

Conclusions: The infusion of sodium ferric gluconate complex to pediatric patients who receive hemodialysis appears to result in a delayed transfer of iron to transferrin, likely after an initial movement through the reticuloendothelial system. Differences noted between the pediatric and adult pharmacokinetic data may result from the unique aspects of the study populations and the respective study designs.