title: Sodium ferric gluconate complex therapy in anemic children on hemodialysis.
abstract: Pediatric patients with end-stage renal disease undergoing hemodialysis (HD) frequently develop anemia. Administration of recombinant human erythropoietin (rHuEPO) is effective in managing this anemia, although the additional demand for iron often results in iron deficiency. In adult patients undergoing HD, intravenous (IV) iron administration is known to replenish iron stores more effectively than oral iron administration. Nevertheless, IV iron supplementation is underutilized in pediatric patients, possibly because of unproved safety in this population. This international, multicenter study investigated the safety and efficacy of two dosing regimens (1.5 mg kg(-1) and 3.0 mg kg(-1)) of sodium ferric gluconate complex (SFGC) therapy, during eight consecutive HD sessions, in iron-deficient pediatric HD patients receiving concomitant rHuEPO therapy. Safety was evaluated in 66 patients and efficacy was evaluated in 56 patients. Significant increases from baseline were observed in both treatment groups 2 and 4 weeks after cessation of SFGC dosing for mean hemoglobin, hematocrit, transferrin saturation, serum ferritin, and reticulocyte hemoglobin content. Efficacy and safety profiles were comparable for 1.5 mg kg(-1) and 3.0 mg kg(-1) SFGC with no unexpected adverse events with either dose. Administration of SFGC was safe and efficacious in the pediatric HD population. Given the equivalent efficacy of the two doses, an initial dosing regimen of 1.5 mg kg(-1) is recommended for pediatric HD patients.
authors.affiliation: The Children's Mercy Hospital, 2401 Gillham Road, Kansas City, MO 64108, USA. bwarady@cmh.edu
authors.forename: Bradley A
authors.initials: BA
authors.lastname: Warady
authors.forename: R Howard
authors.initials: RH
authors.lastname: Zobrist
authors.forename: Jingyang
authors.initials: J
authors.lastname: Wu
authors.forename: Eileen
authors.initials: E
authors.lastname: Finan
mesh_terms: D000293:Adolescent; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004921:Erythropoietin / Q000627:therapeutic use; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D006397:Hematinics / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008297:Male; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D005290:Ferric Compounds; D006397:Hematinics; D011994:Recombinant Proteins; D004921:Erythropoietin; C035552:ferric gluconate