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Sodium ferric gluconate complex therapy in anemic children on hemodialysis

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An Erratum to this article was published on 28 October 2005

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.

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Acknowledgments

The authors wish to acknowledge the contributions of Wendy Arnone, PhD, from Watson Laboratories, Inc., the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS)* organization, and Pharm-Olam International (UK), Ltd. Ferrlecit Pediatric Study Group: Amira Peco-Antic, University Children’s Hospital, Tirsova, Serbia; Nadine M. Benador,* University of California, San Diego, USA; Mark R. Benfield,* University of Alabama at Birmingham, USA; Igor V. Diatchenko, Russian Children’s Clinical Hospital, Moscow, Russia; Tomasz Jarmolinski, Children’s and Teenager’s Hospital, Szczecin, Poland; Rasim K. Kuanshkaliev, Children’s Municipal Hospital #1, St. Petersburg, Russia; Vladimir I. Kudinov, Republic Children’s Clinical Hospital of Ministry of Health, Bashkortostan, Russia; Gary R. Lerner,* Children’s Hospital—Los Angeles, USA; Ewa Marczak, Children Nephrology Clinic of Independent Public Children Hospital No. 1 of Academic Clinical Centre Medical Academy, Gdansk, Poland; Georgy K. Nazarov, Children’s Municipal Hospital #13, Moscow, Russia; Michal Nowicki, Polish Mother’s Memorial Hospital Research Institute, Lodz, Poland; ll’dar D. Shakirov, Children’s Republic Clinical Hospital of Ministry of Health, Tartarstan, Russia; Roman Stankiewicz, Hemodialysis Station of Department Children Hospital, Torun, Poland; Krystyna Szprynger, Childhood Independent Public Clinic Hospital, Zabrze, Poland; Alfredo Chew-Wong, Hospital Miguel Hidalgo, Aguascalientes, Mexico; Peter D. Yorgin,* Stanford University Medical Center, USA; Maria Malgorzata Zajaczkowska, Clinical Children’s Hospital Pediatry and Nephrology Clinic, Lublin, Poland; Dmitriy V. Zverev, Saint Vladimir Children’s Municipal Clinical Hospital, Moscow, Russia; Walentyna Zoch-Zwierz, 1st Children’s Disease Clinic of Medical Academy, Independent Public Clinic Hospital, Bialystok, Poland; Danuta Zwolinska, Medical Academy, Wroclaw, Poland. This work has been submitted in part to the American Society of Nephrology for presentation at the 2004 Annual meeting of the Society. This trial was supported by a grant from Watson Pharmaceuticals, to each of the participating centers.

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Authors and Affiliations

  1. The Children’s Mercy Hospital, 2401 Gillham Road, Kansas City, MO, 64108, USA

    Bradley A. Warady

  2. Watson Laboratories Inc., Salt Lake City, UT, 84108, USA

    R. Howard Zobrist, Jingyang Wu & Eileen Finan

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  1. Bradley A. Warady
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The Ferrlecit Pediatric Study Group

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Correspondence to Bradley A. Warady.

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An erratum to this article can be found at http://dx.doi.org/10.1007/s00467-005-2134-z

The Ferrlecit Pediatric Study Group is a co-author of this paper

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Warady, B.A., Zobrist, R.H., Wu, J. et al. Sodium ferric gluconate complex therapy in anemic children on hemodialysis. Pediatr Nephrol 20, 1320–1327 (2005). https://doi.org/10.1007/s00467-005-1904-y

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