Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 May;36(5):1233-1244.
doi: 10.1007/s00467-020-04805-y. Epub 2020 Oct 27.

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
Affiliations
Free PMC article
Randomized Controlled Trial

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

Larry A Greenbaum et al. Pediatr Nephrol. 2021 May.
Free PMC article

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.

Keywords: Children; Chronic kidney disease; Hyperphosphatemia; Phosphate binder; Safety profile; Sucroferric oxyhydroxide.

PubMed Disclaimer

Conflict of interest statement

Larry A. Greenbaum and Günter Klaus have served as consultants for Vifor Pharmaceuticals. Larysa Wickman has served as a consultant for Novartis Pharma. Amandine Perrin and Milica Enoiu are employees of Vifor Pharma.

Figures

Fig. 1
Fig. 1
Study design. **Age-related sP targets for washout period 0 to < 6 months, > 8.1 mg/dL; ≥ 6 months to < 1 year, > 7.1 mg/dL; ≥ 1 year to < 6 years, > 6.3 mg/dL; ≥ 6 years to < 13 years, > 5.5 mg/dL; ≥ 13 years to < 18 years, > 4.2 mg/dL. †Age-related sP targets post-randomization 0 to 1 year, 5.0–7.8 mg/dL; ≥ 1 year to < 6 years, 4.5–6.5 mg/dL; ≥ 6 years to < 13 years, 3.6–5.8 mg/dL; ≥ 13 years to < 18 years, 2.3–4.5 mg/dL [27]. ††All subjects (including withdrawn) followed for 14 days after the last study visit. PBs, phosphate binders; sP, serum phosphorus
Fig. 2
Fig. 2
Patient disposition (stage 1 and stage 2). SFOH, sucroferric oxyhydroxide. Note: More than one reason for study withdrawal may have been given for an individual subject
Fig. 3
Fig. 3
Mean change (± SEM) from baseline in serum phosphorus levels to end of stage 2 in the sucroferric oxyhydroxide group (FAS; N = 65). FAS, full analysis set; SEM, standard error of the mean. Data are from central laboratory
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Hruska KA, Mathew S, Lund R, Qiu P, Pratt R. Hyperphosphatemia of chronic kidney disease. Kidney Int. 2008;74:148–157. doi: 10.1038/ki.2008.130. - DOI - PMC - PubMed
    1. Kidney Disease: Improving Global Outcomes CKD-MBD Working Group (2009) KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int Suppl:S1–S130 - PubMed
    1. Block GA, Hulbert-Shearon TE, Levin NW, Port FK. Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis. 1998;31:607–617. doi: 10.1053/ajkd.1998.v31.pm9531176. - DOI - PubMed
    1. Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004;15:2208–2218. doi: 10.1097/01.ASN.0000133041.27682.A2. - DOI - PubMed
    1. Ganesh SK, Stack AG, Levin NW, Hulbert-Shearon T, Port FK. Association of elevated serum PO(4), Ca x PO(4) product, and parathyroid hormone with cardiac mortality risk in chronic hemodialysis patients. J Am Soc Nephrol. 2001;12:2131–2138. - PubMed

Publication types