title: The effects of colestilan versus placebo and sevelamer in patients with CKD 5D and hyperphosphataemia: a 1-year prospective randomized study.
abstract: BACKGROUND
  This study compared the effects of short-term titrated colestilan (a novel non-absorbable, non-calcium, phosphate binder) with placebo, and evaluated the safety and efficacy of colestilan over 1 year compared with sevelamer, in patients with chronic kidney disease (CKD) 5D.
  
  
  METHODS
  This prospective multicentre study comprised a 4-week phosphate binder washout period, a 16-week short-term, flexible-dose, treatment period (including a 4-week placebo-controlled withdrawal period) and a 40-week extension treatment phase.
  
  
  RESULTS
  At Week 16 (the end of the 4-week placebo-controlled withdrawal period), serum phosphorus level was 0.43 mmol/L (1.32 mg/dL) lower with colestilan than placebo (P < 0.001; primary end point). Serum LDL-C level was also lower with colestilan than with placebo (P < 0.001). Both colestilan and sevelamer produced significant reductions from baseline in serum phosphorus levels (P < 0.001), maintained for 1 year, and the proportion of patients achieving target levels of ≤1.78 mmol/L (5.5 mg/dL) or ≤1.95 mmol/L (6.0 mg/dL) at study end were similar (65.3 and 73.3%, respectively, for colestilan, and 66.9 and 77.4%, respectively, for sevelamer). Serum calcium level remained stable in the colestilan group but tended to increase slightly in the sevelamer group (end-of-study increase of 0.035 mmol/L over baseline). Both binders produced similar reductions from baseline in LDL-C level (P < 0.001), and responder rates after 1 year, using a target of <1.83 mmol/L (70 mg/dL) or <2.59 mmol/L (100 mg/dL) were similar in both groups (50.7 and 85.3% for colestilan and 54.0 and 80.6% for sevelamer). Colestilan was generally well tolerated.
  
  
  CONCLUSIONS
  Colestilan is effective and safe for the treatment of hyperphosphataemia in patients with CKD 5D, and affords similar long-term phosphorus and cholesterol reductions/responder rates to sevelamer.
authors.affiliation: Department of Nephrology Dialysis and Renal Transplantation, A Manzoni Hospital, Lecco, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
authors.forename: Goce
authors.initials: G
authors.lastname: Spasovski
authors.forename: Nada
authors.initials: N
authors.lastname: Dimkovic
authors.forename: Christoph
authors.initials: C
authors.lastname: Wanner
authors.forename: Frank
authors.initials: F
authors.lastname: Dellanna
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pontoriero
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001647:Bile Acids and Salts / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002118:Calcium / Q000097:blood; D002784:Cholesterol / Q000097:blood; D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D010758:Phosphorus / Q000097:blood; D011073:Polyamines / Q000627:therapeutic use*; D011446:Prospective Studies; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000628:therapy*; D000069603:Sevelamer; D055815:Young Adult
chemical_list: D001647:Bile Acids and Salts; D015415:Biomarkers; D011073:Polyamines; D010758:Phosphorus; D002784:Cholesterol; D000069603:Sevelamer; D002118:Calcium; C106574:cholebine
keywords: chronic kidney disease; colestilan; hyperphosphataemia; placebo; sevelamer