Hertel, Joachim (56156141700)Joachim (56156141700)HertelLocatelli, Francesco (7202821559)Francesco (7202821559)LocatelliSpasovski, Goce (6602271573)Goce (6602271573)SpasovskiDimkovic, Nada (6603958094)Nada (6603958094)DimkovicWanner, Christoph (57212349814)Christoph (57212349814)Wanner2025-07-022025-07-022015https://doi.org/10.1159/000431289https://www.scopus.com/inward/record.uri?eid=2-s2.0-84969593648&doi=10.1159%2f000431289&partnerID=40&md5=e3c251bde277e3998adcbbd71934f879https://remedy.med.bg.ac.rs/handle/123456789/13605Background/Aims: 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. Conclusion: 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. © 2015 S. Karger AG, Basel. All rights reserved.Chronic kidney diseaseColestilanDialysisHyperphosphatemiaMCI-196