Effect of Sodium Zirconium Cyclosilicate on Potassium Lowering for 28 Days Among Outpatients With Hyperkalemia The HARMONIZE Randomized Clinical Trial
Mikhail Kosiborod, Henrik S Rasmussen, Philip Lavin, Wajeh Y Qunibi, Bruce Spinowitz, David Packham, Simon D Roger, Alex Yang, Edgar Lerma, Bhupinder Singh
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | AMER MEDICAL ASSOC | Published : 2014
IMPORTANCE: Hyperkalemia is a common electrolyte abnormality that may be difficult to manage because of a lack of effective therapies. Sodium zirconium cyclosilicate is a nonabsorbed cation exchanger that selectively binds potassium in the intestine. OBJECTIVE: To evaluate the efficacy and safety of zirconium cyclosilicate for 28 days in patients with hyperkalemia. DESIGN, SETTING, AND PARTICIPANTS: HARMONIZE was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating zirconium cyclosilicate in outpatients with hyperkalemia (serum potassium ≥5.1 mEq/L) recruited from 44 sites in the United States, Australia, and South Africa (March-August 2014). INTERVENTIONS: P..View full abstract
The study was sponsored and funded by ZS Pharma.