Safety and efficacy of sucroferric oxyhydroxide in pediatric patients with chronic kidney disease

• Type of Material: Article
• Authors: Larry Greenbaum, Emory University; Nikola Jeck, Philipps University; Günter Klaus, Philipps University; Marc Fila, CHU Hop Arnaud de Villeneuve; Cristina Stoica, Institutul Clinic Fundeni; Sahar Fathallah-Shaykh, University of Alabama Birmingham; Ana Paredes, Nicklaus Childrens Hospital; Larysa Wickman, CS Mott Childrens Hospital; Raoul Nelson, University of Utah; Rita D. Swinford, University of Texas Medical School at Houston; Carolyn Larkins Abitbol, University of Miami; Mihaela Balgradean, Spitalul Clin Urgenta Pentru Copii Maria Sklodows; Augustina Jankauskiene, Vilnius University; Amandine Perrin, Vifor Pharma Management Ltd; Milica Enoiu, Vifor Pharma Management Ltd; Sun-Young Ahn, George Washington University
• Language: English
• Date: 2020-10-27
• Publisher: Springer
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2020
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1007/s00467-020-04805-y
• Title of Journal or Parent Work: Pediatric Nephrology
• Volume: 36
• Issue: 5
• Start Page: 1233
• End Page: 1244
• Grant/Funding Information: This study was sponsored by Vifor Fresenius Medical Care Renal Pharma France.
• Keywords: Lanthanum deposition; Serum phosphorus; Oral calcium carbonate; Children; Sucroferric oxyhydroxide; Pediatrics; Science & Technology; Phosphate binder; Hemodialysis patients; Metabolism; Young adults; Hyperphosphatemia; Chronic kidney disease; Safety profile; Life Sciences & Biomedicine; Urology & Nephrology; Mortality risk
• Research Categories: Health Sciences, Public Health; Health Sciences, Human Development; Health Sciences, Health Care Management

Abstract

Background Pediatric patients with advanced chronic kidney disease (CKD) are often prescribed oral phosphate binders (PBs) for the management of hyperphosphatemia. However, available PBs have limitations, including unfavorable tolerability and safety. Methods This phase 3, multicenter, randomized, open-label study investigated safety and efficacy of sucroferric oxyhydroxide (SFOH) in pediatric and adolescent subjects with CKD and hyperphosphatemia. Subjects were randomized to SFOH or calcium acetate (CaAc) for a 10-week dose titration (stage 1), followed by a 24-week safety extension (stage 2). Primary efficacy endpoint was change in serum phosphorus from baseline to the end of stage 1 in the SFOH group. Safety endpoints included treatment-emergent adverse events (TEAEs). Results Eighty-five subjects (2–18 years) were randomized and treated (SFOH, n = 66; CaAc, n = 19). Serum phosphorus reduction from baseline to the end of stage 1 in the overall SFOH group (least squares [LS] mean ± standard error [SE]) was − 0.488 ± 0.186 mg/dL; p = 0.011 (post hoc analysis). Significant reductions in serum phosphorus were observed in subjects aged ≥ 12 to ≤ 18 years (LS mean ± SE − 0.460 ± 0.195 mg/dL; p = 0.024) and subjects with serum phosphorus above age-related normal ranges at baseline (LS mean ± SE − 0.942 ± 0.246 mg/dL; p = 0.005). Similar proportions of subjects reported ≥ 1 TEAE in the SFOH (75.8%) and CaAc (73.7%) groups. Withdrawal due to TEAEs was more common with CaAc (31.6%) than with SFOH (18.2%). Conclusions SFOH effectively managed serum phosphorus in pediatric patients with a low pill burden and a safety profile consistent with that reported in adult patients.