Abstract

Hyperphosphatemia is a common complication in dialysis-dependent patients with chronic kidney disease. Most dialysis-dependent patients need oral phosphate binder therapy to control serum phosphorus concentrations. Most phosphate binders have a high daily pill burden, which may reduce treatment adherence and impair phosphorus control. Sucroferric oxyhydroxide is a potent iron-based phosphate binder approved for use in dialysis-dependent patients in 2013. A randomized controlled trial of sucroferric oxyhydroxide demonstrated its efficacy for reduction of serum phosphorus with a lower pill burden than sevelamer carbonate. Clinical trials carefully select patients, monitor adherence, and routinely titrate medications to a protocol-defined goal. Consequently, trials may not reflect real-world use of medications. Since its approval, we and others have performed retrospective and prospective analyses of sucroferric oxyhydroxide in real-world clinical practice in > 6400 hemodialysis and approximately 500 peritoneal dialysis patients in the USA and Europe. Consistent with the clinical trial data, real-world observational studies have demonstrated that sucroferric oxyhydroxide can effectively reduce serum phosphorus with a lower daily pill burden than most other phosphate binders. These studies have also shown sucroferric oxyhydroxide provides effective serum phosphorus control in different treatment settings, including as monotherapy in phosphate binder-naïve patients, in patients switching from other phosphate binders, or when used in combination with other phosphate binders. These observational studies indicate a favorable safety and tolerability profile, and minimal, if any, systemic iron absorption. This article reviews the key results from these observational studies of sucroferric oxyhydroxide and evaluates its role in the management of hyperphosphatemia in clinical practice.

Highlights

  • Hyperphosphatemia is a frequent complication in patients with dialysis-dependent chronic kidney disease [1]

  • This study shows that addition of Sucroferric oxyhydroxide (SO) to other phosphate binders (PBs) regimens improves the proportion of patients achieving phosphorus goal, but does not decrease PB pill burden [38]

  • The results showed that both hypo­ albuminemic and non-hypoalbuminemic patients switched to SO achieved reductions in serum phosphorus (– 0.40 g/dl and – 0.51 g/dl, respectively) and daily PB pill burden

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Summary

Introduction

Hyperphosphatemia is a frequent complication in patients with dialysis-dependent chronic kidney disease [1]. The SO 24-week Phase 3 clinical trial, conducted in 1,055 hemodialysis and peritoneal dialysis patients, demonstrated that SO was non-inferior to sevelamer carbonate (“sevelamer”) for reduction of serum phosphorus after 12 weeks, with a lower daily pill burden (2.8 pills/day vs 7.6 pills/day) and better treatment adherence (82.6% vs 77.2% at Week 24) [26]. These reductions in serum phosphorus with SO were sustained during the subsequent 28-week extension study [27]. The effectiveness of SO has been evaluated prospectively by VERIFIE

Summary of key results
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Findings
12. Kidney Disease
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