title: A randomized trial of JTT-751 versus sevelamer hydrochloride in patients on hemodialysis.
abstract: BACKGROUND
  JTT-751 is a novel phosphate binder containing ferric citrate as the active ingredient.
  
  
  METHODS
  In this Phase 3, multicenter, randomized, open-label, parallel-group study, we compared the efficacy and safety of JTT-751 and sevelamer hydrochloride in patients undergoing hemodialysis. A total of 230 patients with a serum phosphate ≥1.97 and <3.23 mmol/L were randomized to JTT-751 (dose adjusted between 1.5 and 6.0 g/day) or sevelamer hydrochloride (dose adjusted between 3.0 and 9.0 g/day) for 12 weeks. The primary outcome was change in serum phosphate from baseline to end of treatment. Secondary outcomes included the changes in corrected serum calcium and intact parathyroid hormone (PTH). The changes in ferritin, transferrin saturation and erythropoiesis-stimulating agent dose were additional outcomes.
  
  
  RESULTS
  Changes in serum phosphate at the end of treatment were -0.82 mmol/L in the JTT-751 group and -0.78 mmol/L in the sevelamer group, establishing non-inferiority of JTT-751 compared with sevelamer (least squares mean, -0.03 mmol/L; 95% confidence interval, -0.13 to 0.07 mmol/L). Corrected serum calcium increased and PTH decreased from baseline within both groups; changes between groups were similar. Gastrointestinal disorders were the most common adverse events in both groups; the incidence of diarrhea was higher in the JTT-751 group, while constipation occurred frequently in the sevelamer group. Treatment with JTT-751 resulted in significant relative increases in serum ferritin and transferrin saturation.
  
  
  CONCLUSIONS
  Efficacy and safety of JTT-751 was comparable to sevelamer in patients on hemodialysis with hyperphosphatemia. Differential adverse effects were observed; biochemical markers of iron status increased in patients treated with JTT-751.
  
  
  BACKGROUND
  CTI-111433 (The Japan Pharmaceutical Information Center at: http//www.clinicaltrials.jp). Date of registration: 7 March 2011.
authors.affiliation: Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Keitaro
authors.initials: K
authors.lastname: Yokoyama
authors.forename: Takashi
authors.initials: T
authors.lastname: Akiba
authors.forename: Masafumi
authors.initials: M
authors.lastname: Fukagawa
authors.forename: Masaaki
authors.initials: M
authors.lastname: Nakayama
authors.forename: Kenichi
authors.initials: K
authors.lastname: Sawada
authors.forename: Yuji
authors.initials: Y
authors.lastname: Kumagai
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Chertow
authors.forename: Hideki
authors.initials: H
authors.lastname: Hirakata
mesh_terms: D000328:Adult; D002614:Chelating Agents / Q000627:therapeutic use*; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D006801:Humans; D054559:Hyperphosphatemia / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D007564:Japan; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D011073:Polyamines / Q000627:therapeutic use*; D006435:Renal Dialysis; D000069603:Sevelamer; D055815:Young Adult
chemical_list: D002614:Chelating Agents; D005290:Ferric Compounds; D010281:Parathyroid Hormone; D011073:Polyamines; C025314:ferric citrate; D000069603:Sevelamer
keywords: clinical trial; ferric citrate; hemodialysis; hyperphosphatemia; phosphate binder