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. Issue 4 (April 2017)

• Record Type: Journal Article
• Authors: Koiwa, Fumihiko; Yokoyama, Keitaro; Fukagawa, Masafumi; Terao, Akira; Akizawa, Tadao
• Is Part Of: Nephrology. Volume 22:Issue 4(2017)
• Page Start: 293
• Page End: 300
• Publication Date: 2017-04
• Subjects: haemodialysis -- hyperphosphataemia -- PA21 compound -- sevelamer -- sucroferric oxyhydroxide; Nephrology -- Periodicals; Kidneys -- Diseases -- Periodicals; Nephrologists -- Periodicals; 616.61; 616.61
• DOI: 10.1111/nep.12891
• Languages: English
• ISSNs: 1320-5358

Abstract

Abstract: 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. Summary at a Glance: This short‐term randomized trial of PA21 (sucroferric oxyhydroxide) performed in Japanese haemodialysis patients was able to demonstrate non‐inferiority for phosphorus lowering with a significantly lower pill burden.