Efficacy and Safety of a Novel Nicotinamide Modified-Release Formulation in the Treatment of Refractory Hyperphosphatemia in Patients Receiving Hemodialysis—A Randomized Clinical Trial
Markus Ketteler, Andrzej Więcek, Alexander R. Rosenkranz, Andreas Pasch, Jan Rekowski, Burkhard Hellmann, Michael Karus, Richard Ammer
Abstract
INTRODUCTION: Despite widespread use of phosphate binders (PBs), phosphate control is insufficient in many hemodialysis patients. Preliminary clinical observations suggest that nicotinamide may act synergistically with PBs to improve phosphate control. METHODS: This multinational, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of nicotinamide modified release (NAMR) in combination with oral PB in a large cohort of hemodialysis patients with abnormal serum phosphate concentration (>4.5 mg/dl) despite treatment with PB. Patients entered a proof-of-efficacy phase (12 weeks [W12]) in which adjustments of relevant comedication were not permitted, followed by a safety extension phase for up to 52 weeks. Here, we report the results of the first phase. RESULTS: = 0.02). Diarrhea and pruritus were more frequent in the NAMR group. CONCLUSION: NAMR combined with oral PB significantly improved phosphate control in hemodialysis patients.