A review of ferric citrate clinical studies, and the rationale and design of the Ferric Citrate and Chronic Kidney Disease in Children (FIT4KiD) trial.

TitleA review of ferric citrate clinical studies, and the rationale and design of the Ferric Citrate and Chronic Kidney Disease in Children (FIT4KiD) trial.
Publication TypeJournal Article
Year of Publication2022
AuthorsHanudel MR, Laster ML, Portale AA, Dokras A, Quigley RP, Guzman GALozano, Zaritsky JJ, Hayde NA, Kaskel FJ, Mitsnefes MM, Ramirez JA, Imani PD, Srivaths PR, Kogon AJ, Denburg MR, Blydt-Hansen TD, Reyes LZ, Greenbaum LA, Weidemann DK, Warady BA, Elashoff DA, Mendley SR, Isakova T, Salusky IB
JournalPediatr Nephrol
Date Published2022 Mar 02
ISSN1432-198X
Abstract

Pediatric chronic kidney disease (CKD) is characterized by many co-morbidities, including impaired growth and development, CKD-mineral and bone disorder, anemia, dysregulated iron metabolism, and cardiovascular disease. In pediatric CKD cohorts, higher circulating concentrations of fibroblast growth factor 23 (FGF23) are associated with some of these adverse clinical outcomes, including CKD progression and left ventricular hypertrophy. It is hypothesized that lowering FGF23 levels will reduce the risk of these events and improve clinical outcomes. Reducing FGF23 levels in CKD may be accomplished by targeting two key stimuli of FGF23 production-dietary phosphate absorption and iron deficiency. Ferric citrate is approved for use as an enteral phosphate binder and iron replacement product in adults with CKD. Clinical trials in adult CKD cohorts have also demonstrated that ferric citrate decreases circulating FGF23 concentrations. This review outlines the possible deleterious effects of excess FGF23 in CKD, summarizes data from the adult CKD clinical trials of ferric citrate, and presents the Ferric Citrate and Chronic Kidney Disease in Children (FIT4KiD) study, a randomized, placebo-controlled trial to evaluate the effects of ferric citrate on FGF23 in pediatric patients with CKD stages 3-4 (ClinicalTrials.gov Identifier NCT04741646).

DOI10.1007/s00467-022-05492-7
Alternate JournalPediatr Nephrol
PubMed ID35237863
Grant ListK23 DK123378 / DK / NIDDK NIH HHS / United States
U01 DK122013 / DK / NIDDK NIH HHS / United States
U01-DK122013 / DK / NIDDK NIH HHS / United States
K23-DK123378 / DK / NIDDK NIH HHS / United States