EC approves label update of potassium binder for patients with hyperkalemia on stable hemodialysisNews - May 11, 2020
Patients with hyperkalemia on stable hemodialysis are included under a dosing and administration label update for treatment with sodium zirconium cyclosilicate , a highly selective potassium-removing medicine. The label update has been approved in the EU by the European Commission (EC) and is based on data from the DIALIZE trial, which showed sustained potassium control pre-dialysis for more patients receiving sodium zirconium cyclosilicate, compared with placebo.
The DIALIZE trial is a phase IIIb, multicenter, double-blinded, randomized, placebo-controlled trial, which evaluated the efficacy and safety of sodium zirconium cyclosilicate, by randomizing patients with hyperkalemia on stable hemodialysis (n=196) to either sodium zirconium cyclosilicate or placebo. Patients received treatment orally once daily on non-dialysis days for a treatment period of eight weeks, including a four-week dose adjustment phase and a four-week evaluation phase on stable dose. The trial showed that 41% of patients receiving sodium zirconium cyclosilicate , as compared to 1% of patients receiving placebo, maintained pre-dialysis potassium levels on at least three out of four dialysis treatments after the long interdialytic interval and did not require urgent rescue therapy. The safety profile of sodium zirconium cyclosilicate was consistent with results from previous trials.
Sodium zirconium cyclosilicate is currently approved in the EU, US, Canada, Japan, China and Russia for treatment of hyperkalemia. The FDA recently approved a label update for sodium zirconium cyclosilicate in the US to include a dosing regimen to treat hyperkalemia in patients with end-stage renal disease on hemodialysis. Hyperkalemia and fluctuations in potassium levels are common in patients with chronic kidney disease (CKD), despite these patients being on hemodialysis.