title: 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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors: Division of Nephrology, Department of Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.
authors: Fumihiko
authors: F
authors: Koiwa
authors: Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
authors: Keitaro
authors: K
authors: Yokoyama
authors: Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan.
authors: Masafumi
authors: M
authors: Fukagawa
authors: Biostatistics, Faculty of Pharmaceutical Sciences, Josai University, Sakado, Japan.
authors: Akira
authors: A
authors: Terao
authors: Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
authors: Tadao
authors: T
authors: Akizawa
mesh_terms: D000284:Administration, Oral; D000368:Aged; D015415:Biomarkers / Q000097:blood; D002118:Calcium / Q000097:blood; D002614:Chelating Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D054559:Hyperphosphatemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D007564:Japan; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood*; D006435:Renal Dialysis / Q000009:adverse effects; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D000069603:Sevelamer / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013395:Sucrose / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013607:Tablets; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D002614:Chelating Agents; D004338:Drug Combinations; D005290:Ferric Compounds; C470125:PTH protein, human; D010281:Parathyroid Hormone; D013607:Tablets; C000599459:sucroferric oxyhydroxide; D010758:Phosphorus; D013395:Sucrose; D000069603:Sevelamer; D002118:Calcium
keywords: PA21 compound; haemodialysis; hyperphosphataemia; sevelamer; sucroferric oxyhydroxide