LOKELMATM Sodium Zirconium Cyclosilicate

SWIFT* K+ REDUCTION AFTER ONE HOUR.1,2
SUSTAINED K+ CONTROL FOR UP TO ONE YEAR
WHEN USED AS A MAINTENANCE THERAPY.†1
NOW IN YOUR HANDS.
New, highly-selective LOKELMA (sodium zirconium cyclosilicate)
is indicated for the treatment of hyperkalaemia in adult patients1

*In an emergency situation, standard of care should be used in line with local or national guidelines
Clinical trials with LOKELMA have not included exposure longer than one year

Clinical Studies

HARMONIZE Study Overview

HARMONIZE (ZS004), a Phase III, multicentre, multiphase, placebo-controlled study in 258 patients with hyperkalaemia. Open-label phase: LOKELMA 10 g three times daily, administered for 48 hours, at which time patients (n=237) with normokalaemia (3.5-5.0 mmol/L) were randomised to LOKELMA or placebo once daily, 5 g, 10 g, or 15 g, for 28 days.
Primary endpoint: mean serum K+ level with LOKELMA vs placebo on days 8-29. Eligible patients then continued treatment with LOKELMA 10 g once daily, which could be titrated to 5 g or 15 g, in an 11-month, open-label extension study (ZS004E). Please note that LOKELMA 15 g is not approved for use.1,2,23

LOKELMA HARMONIZE study overview1,2,23

HARMONIZE (ZS004) was a phase III, double-blind, randomised, multicentre trial (N=258) with extension phase (ZS004E)
HARMONIZE (ZS004) was a phase III, double-blind, randomised, multicentre trial (N=258) with extension phase (ZS004E)

* LOKELMA 15 g is not approved for use in the UK; 56 patients were randomised to 15 g maintenance therapy.
Patients enrolled in ZS004E received LOKELMA 10 g once daily, which could be titrated to LOKELMA 5 g once daily or LOKELMA 15 g once daily. Please note that the recommended starting dose for maintenance therapy with LOKELMA is
5 g once daily, which may be titrated to 10 g once daily as needed. No more than 10 g once daily should be used for maintenance therapy. The 5 g once daily dose can be down titrated to 5 g every other day.1,23

 

Primary endpoint

  • Comparison of mean serum K+ level on days 8–29 (ZS004)2
  • Maintenance of normokalaemia for 11 months (ZS004E)23

Secondary endpoints included

  • Proportion of patients who achieve and maintain normokalaemia2
  • Absolute and percentage change in serum K+ levels from baseline2