title: Long-Term Evaluation of Colestilan in Chronic Kidney Disease Stage 5 Dialysis Patients with Hyperphosphataemia.
abstract: BACKGROUND
  This study investigated in a North American patient population the longer-term treatment effects of the phosphate binder, colestilan, in patients with CKD Stage 5D and hyperphosphataemia.
  
  
  METHODS
  One hundred and sixteen CKD Stage 5D patients with hyperphosphataemia were entered into a multi-centre, open-label study where they received flexible dose colestilan (6-15 g/day) to maintain serum phosphorus levels between 3.5 and 5.5 mg/dl. The primary endpoint was safety, assessed by treatment-emergent adverse events. Efficacy was assessed by changes in serum phosphorus, mineral metabolism, lipids, HbA1c, uric acid and bone markers.
  
  
  RESULTS
  Serum phosphorus was significantly reduced by 1.18 mg/dl (p < 0.001), from 6.99 mg/dl at baseline to 5.80 mg/dl at week 52. LDL-cholesterol was also significantly reduced as well as uric acid. Significant change was observed only for one bone marker - PINP. Most adverse events were of mild or moderate intensity. Nausea (22.4%), vomiting (21.6%), and diarrhoea (19.8%) were most commonly reported.
  
  
  CONCLUSIONS
  Long-term flexible dosing with colestilan reduces serum phosphorus and demonstrates an acceptable safety and tolerability profile.
authors.affiliation: Department of Nephrology, Alessandro 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
mesh_terms: D000328:Adult; D000368:Aged; D001647:Bile Acids and Salts / Q000008:administration & dosage* / Q000009:adverse effects; D008078:Cholesterol, LDL / Q000097:blood; D003967:Diarrhea / Q000209:etiology / Q000503:physiopathology; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D015312:Hemodialysis Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D054559:Hyperphosphatemia / Q000097:blood / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000209:etiology / Q000503:physiopathology; D010446:Peptide Fragments / Q000097:blood; D010710:Phosphates / Q000097:blood; D010758:Phosphorus / Q000097:blood*; D011347:Procollagen / Q000097:blood; D006435:Renal Dialysis / Q000379:methods*; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D014527:Uric Acid / Q000097:blood; D014839:Vomiting / Q000209:etiology / Q000503:physiopathology
chemical_list: D001647:Bile Acids and Salts; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D015312:Hemodialysis Solutions; D010446:Peptide Fragments; D010710:Phosphates; D010758:Phosphorus; D011347:Procollagen; D014527:Uric Acid; C517652:hemoglobin A1c protein, human; C047202:procollagen Type I N-terminal peptide; C106574:cholebine