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Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomized, open‐label, multicentre, 12‐week phase III study
Author(s) -
Koiwa Fumihiko,
Yokoyama Keitaro,
Fukagawa Masafumi,
Terao Akira,
Akizawa Tadao
Publication year - 2017
Publication title -
nephrology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.752
H-Index - 61
eISSN - 1440-1797
pISSN - 1320-5358
DOI - 10.1111/nep.12891
Subject(s) - sevelamer , medicine , adverse effect , phosphate binder , confidence interval , gastroenterology , parathyroid hormone , urology , hyperphosphatemia , calcium
Aim We aimed to investigate the non‐inferiority of PA21 (sucroferric oxyhydroxide) to sevelamer hydrochloride (sevelamer) in terms of efficacy and safety in Japanese haemodialysis patients with hyperphosphataemia. Methods In this Phase III, open‐label, multicentre study, 213 haemodialysis patients with hyperphosphataemia were randomized to PA21 or sevelamer treatment for 12 weeks. The primary outcome was adjusted serum phosphorus concentration at the end of treatment; the non‐inferiority of PA21 was confirmed if the upper limit of the two‐sided 95% confidence interval (CI) is ≤0.32 mmol/L. Secondary outcomes were corrected serum calcium and intact‐parathyroid hormone concentrations. Adverse events (AEs) and adverse drug reactions (ADRs) were evaluated. Results The adjusted mean serum phosphorus concentration at the end of treatment confirmed the non‐inferiority of PA21 for lowering serum phosphorus compared with sevelamer (1.62 vs 1.72 mmol/L; difference, −0.11 mmol/L; 95% CI, −0.20 to −0.02 mmol/L). The mean daily tablet intake was 5.6 ± 2.6 and 18.7 ± 7.1 tablets in the PA21 and sevelamer groups, respectively. The incidences of AEs and ADRs were not significantly different between the two groups. Conclusion The non‐inferiority of PA21 to sevelamer was confirmed for the treatment of Japanese haemodialysis patients with hyperphosphataemia. PA21 was effective, safe, and well tolerated, while having a considerably lower pill burden than sevelamer.