Safety and efficacy of sucroferric oxyhydroxide in pediatric patients with chronic kidney disease
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ORIGINAL ARTICLE
Safety and efficacy of sucroferric oxyhydroxide in pediatric patients with chronic kidney disease Larry A. Greenbaum 1 & Nikola Jeck 2 & Günter Klaus 2 & Marc Fila 3 & Cristina Stoica 4 & Sahar Fathallah-Shaykh 5 & Ana Paredes 6 & Larysa Wickman 7 & Raoul Nelson 8 & Rita D. Swinford 9 & Carolyn Larkins Abitbol 10 & Mihaela Balgradean 11 & Augustina Jankauskiene 12 & Amandine Perrin 13 & Milica Enoiu 13 & Sun-Young Ahn 14 Received: 1 January 2020 / Revised: 8 September 2020 / Accepted: 30 September 2020 # The Author(s) 2020
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 treatmentemergent 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. Keywords Chronic kidney disease . Hyperphosphatemia . Children . Phosphate binder . Sucroferric oxyhydroxide . Safety profile
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00467-020-04805-y) contains supplementary material, which is available to authorized users. * Larry A. Greenbaum [email protected]
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C.S Mott Children’s Hospital, Michigan Medicine, Ann Arbor, MI, USA
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University of Utah, Salt Lake City, UT, USA
Division of Pediatric Nephrology, Emory University School of Medicine and Children’s Healthcare of Atlanta, 2015 Uppergate Drive NE, Atlanta, GA 30322, USA
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The University of Texas Medical School at Houston, Houston, TX, USA
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University of Miami - Miller School of Medicine, Miami, FL, USA
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KfH Pediatric Kidney Center and Department of
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