Single‐dose pharmacokinetics (PK) of ferric gluconate (FG) in iron‐deficient pediatric hemodialysis patients

Purpose: Limited information exists on the use of any intravenous iron preparation in pediatric HD patients. This study was designed to describe the PK parameters of FG, now approved for use in children on HD. Methods: Iron‐deficient pediatric HD pts (≤15 yr) were randomized to 2 doses of FG. Blood samples taken during a 1 hr infusion and at intervals over 48 hrs were analyzed for total iron, transferrin‐bound iron (TBI), and FG‐bound iron (FGI). Results: 49% of pts were male, 88% white, 57% age 6–12 yr, wt 16.3–63.2 Kg, ht 100–177.5 cm. Mean serum iron concentrations (total iron and FGI) rapidly increased in a dose‐dependent manner, approximately proportional to the FG dose administered. A rapid rise in total serum iron was followed by a slower, less prominent rise in TBI. Single‐dose PK of FGI was adequately described using non‐compartmental analytical methods. A standard 2‐compartment NONMEM model successfully fit the data and accurately described the time‐course of FGI concentrations.