Document Type
Article
Publication Date
11-2018
Identifier
DOI: 10.1007/s00467-018-4014-3; PMCID: PMC6153505
Abstract
BACKGROUND: Iron deficiency is a common cause of anemia in pediatric patients with hemodialysis-dependent chronic kidney disease (CKD-5HD). Ferric pyrophosphate citrate (FPC, Triferic®) donates iron directly to transferrin, bypassing the reticuloendothelial system and avoiding iron sequestration. Administration of FPC via dialysate or intravenously (IV) may provide a suitable therapeutic option to current IV iron preparations for these patients.
METHODS: The pharmacokinetics and safety of FPC administered via dialysate and IV to patients aged < 6 years (n = 3), 6 to < 12 years (n = 4), and 12 to < 18 years (n = 15) were investigated in a multicenter, open-label, two-period, single-dose study. FPC (0.07 mg iron/kg) was infused IV into the venous blood return line during hemodialysis session no. 1. FPC iron was added to bicarbonate concentrate to deliver 2 μM (110 μg/L) iron via dialysate during hemodialysis session no. 2.
RESULTS: Mean serum total iron concentrations peaked 3 to 4 h after administration via dialysate and 2 to 4 h after IV administration and returned to baseline by 10 h after the start of hemodialysis for both routes. Iron exposure was greater after administration via dialysate than after IV administration. The absolute amount of absorbed iron after administration via dialysate roughly doubled with increasing age, but the weight-normalized amount of absorbed iron was relatively constant across age groups (~ 0.06-0.10 mg/kg). FPC was well tolerated in the small number of patients studied.
CONCLUSIONS: FPC iron can be administered to pediatric patients with CKD-5HD via dialysate or by the IV route. Further study of FPC administered to maintain hemoglobin concentration is indicated.
Journal Title
Pediatric nephrology (Berlin, Germany)
Volume
33
Issue
11
First Page
2151
Last Page
2159
MeSH Keywords
Administration, Intravenous; Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Dialysis Solutions; Diphosphates; Feasibility Studies; Female; Hematinics; Hemoglobins; Humans; Infant; Iron; Male; Renal Dialysis; Renal Insufficiency, Chronic; Treatment Outcome
PubMed ID
30003313
Keywords
Ferric pyrophosphate citrate; Hemodialysis; Iron; Pediatric; Pharmacokinetics.
Recommended Citation
Pratt RD, Grimberg S, Zaritsky JJ, Warady BA. Pharmacokinetics of ferric pyrophosphate citrate administered via dialysate and intravenously to pediatric patients on chronic hemodialysis. Pediatr Nephrol. 2018;33(11):2151-2159. doi:10.1007/s00467-018-4014-3
Comments
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
Publisher's Link: https://link.springer.com/article/10.1007/s00467-018-4014-3