Randomized, Double-Blind, Placebo-Controlled, Withdrawal Study of Colestilan after Dose Titration in Chronic Kidney Disease Dialysis Patients with Hyperphosphatemia

摘要: Background/Aims: Colestilan is a new non-calcium-based phosphate binder licensed in Europe for the treatment of hyperphosphatemia chronic kidney disease patients on dialysis (CKD 5D). This study was conducted to evaluate efficacy North American patient population and also examine secondary actions colestilan lipid profile glycated hemoglobin (HbA1c). Methods: multicenter, randomized, double-blind, placebo-controlled withdrawal study, after an initial open-label titration period. Patients (n = 245) with stable control received 6-15 g/day during 12-week, flexible period which 169 were randomized continue same dose 85) or switch placebo 84) 4 weeks. The primary endpoint change serum phosphorus level Results: A significant difference -1.01 mg/dl (-0.33 mmol/l) mean phosphorus, favoring colestilan, seen (p Conclusion: In this first clinical trial population, demonstrated controlling levels CKD 5D hyperphosphatemia, without increasing calcium levels.