title: Randomized, Double-Blind, Placebo-Controlled, Withdrawal Study of Colestilan after Dose Titration in Chronic Kidney Disease Dialysis Patients with Hyperphosphatemia.
abstract: OBJECTIVE
  Colestilan is a new non-calcium-based phosphate binder licensed in Europe for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis (CKD 5D). This study was conducted to evaluate efficacy in a North American patient population and also to examine secondary actions of colestilan on lipid profile and glycated hemoglobin (HbA1c).
  
  
  METHODS
  This was a multicenter, randomized, double-blind, placebo-controlled withdrawal study, after an initial open-label titration period. Patients (n = 245) with stable phosphate control received 6-15 g/day colestilan during a 12-week, flexible titration period after which 169 were randomized to continue the same dose (n = 85) or switch to placebo (n = 84) for 4 weeks. The primary endpoint was the change in serum phosphorus level during the placebo-controlled withdrawal period.
  
  
  RESULTS
  A significant difference of -1.01 mg/dl (-0.33 mmol/l) in mean change in serum phosphorus, favoring colestilan, was seen during the placebo-controlled withdrawal period (p < 0.001). Colestilan reduced serum phosphorus significantly from baseline to week 12 (-1.54 mg/dl (-0.50 mmol/l); p < 0.001). Serum calcium levels were not affected. Colestilan significantly reduced and maintained reductions in calcium × phosphorus ion product (Ca × P), parathyroid hormone, total cholesterol, low-density lipoprotein cholesterol, uric acid and also HbA1c in patients with elevated baseline HbA1c. Colestilan was generally well tolerated; most adverse events were gastrointestinal.
  
  
  CONCLUSIONS
  In this first clinical trial with colestilan in a North American patient population, colestilan demonstrated significant efficacy in controlling serum phosphorus levels in CKD 5D patients with hyperphosphatemia, without increasing calcium levels.
authors.affiliation: Greenville Kidney Care LLC, Greenville, S.C., USA.
authors.forename: Joachim
authors.initials: J
authors.lastname: Hertel
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
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001647:Bile Acids and Salts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002118:Calcium / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D054559:Hyperphosphatemia / Q000188:drug therapy* / Q000209:etiology*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010758:Phosphorus / Q000097:blood; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001647:Bile Acids and Salts; D002118:Calcium; D006442:Glycated Hemoglobin; D008055:Lipids; D010758:Phosphorus; C106574:cholebine