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Safety and efficacy of sucroferric oxyhydroxide in pediatric patients with chronic kidney disease
Larry A Greenbaum1, Nikola Jeck2, Günter Klaus2
1Division of Pediatric Nephrology, Emory University School of Medicine and Children's Healthcare of Atlanta, 2015 Uppergate Drive NE, Atlanta, GA, 30322, USA. lgreen6@emory.edu.
Insights
Sucroferric oxyhydroxide (SFOH) effectively reduced serum phosphorus in pediatric patients with chronic kidney disease (CKD). This phosphate binder demonstrated a favorable safety profile and lower withdrawal rates compared to calcium acetate.
Area of Science:
- Nephrology
- Pediatric Medicine
- Pharmacology
Background:
- Pediatric patients with advanced chronic kidney disease (CKD) often require phosphate binders (PBs) to manage hyperphosphatemia.
- Existing PBs present challenges related to tolerability and safety in pediatric populations.
Purpose of the Study:
- To evaluate the safety and efficacy of sucroferric oxyhydroxide (SFOH) as a PB in pediatric and adolescent subjects with CKD and hyperphosphatemia.
- To compare SFOH with calcium acetate (CaAc) in managing serum phosphorus levels.
Main Methods:
- A phase 3, multicenter, randomized, open-label study involving 85 pediatric and adolescent subjects (2-18 years).
- Subjects were randomized to receive either SFOH or CaAc for a 10-week dose titration, followed by a 24-week safety extension.
- Primary efficacy endpoint: change in serum phosphorus from baseline to end of titration. Safety endpoints: treatment-emergent adverse events (TEAEs).
Main Results:
- SFOH demonstrated a statistically significant reduction in serum phosphorus levels from baseline in the overall pediatric group (p=0.011).
- Significant phosphorus reductions were noted in adolescents (≥12 to ≤18 years) and in subjects with baseline hyperphosphatemia above age-related normal ranges.
- Similar rates of TEAEs were observed between SFOH (75.8%) and CaAc (73.7%) groups, but withdrawals due to TEAEs were less frequent with SFOH (18.2%) than CaAc (31.6%).
Conclusions:
- Sucroferric oxyhydroxide (SFOH) is an effective option for managing hyperphosphatemia in pediatric patients with CKD.
- SFOH offers a favorable safety profile, consistent with adult data, and a lower pill burden.
- The study supports SFOH as a viable alternative to calcium acetate in this patient population, with improved tolerability.
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.
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