LOKELMA® 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
IN YOUR HANDS.
Highly selective LOKELMA (sodium zirconium cyclosilicate)
is indicated for the treatment of hyperkalaemia in adult patients1

*Median time to normokalaemia was 2.2 hours (Interquartile range, 1.0 to 22.3). In an emergency situation,
standard of care should be used in line with national or local guidelines
Clinical trials with LOKELMA have not included exposure longer than one year

Clinical Studies

DIALIZE Study

LOKELMA reduced K+ levels and sustained K+ control in haemodialysis patients

  • In the DIALIZE study, 196 patients with end stage renal disease and persistent hyperkalaemia despite adequate haemodialysis were evaluated. Patients were randomized 1:1 to receive either LOKELMA 5g or placebo once daily on non-dialysis days, titrated in 5g increments up to a maximum of 15g. Patients were evaluated over a 4-week period25
  • The DIALIZE study is the first, double-blind, randomised, placebo-controlled trial to determine the efficacy and safety of a potassium binder, in haemodialysis patients with hyperkalaemia25

DIALIZE study overview

Primary endpoint

Proportion of patients who maintained predialysis serum K+ 4.0-5.0 mmol/L during at least three of four HD treatments following the long interdialytic interval and who did not require urgent rescue therapy during the 4-week evaluation phase25

Secondary endpoint

Proportion of patients requiring any urgent rescue intervention25

Results

LOKELMA REDUCED K+ LEVEL AND SUSTAINED K+ CONTROL IN HAEMODIALYSIS PATIENTS

Mean predialysis serum k+ levels over time in patients on haemodialysis*1

The displayed error bars correspond to 95% confidence intervals

41% of patients achieved 4.0-5.0 mmol/L (vs 1% for placebo) in at least three of four haemodialysis sessions following the long interdialytic interval, without need for rescue therapy.25

  • *5g once daily on non-dialysis days (titrated in 5g increments weekly to maximum of 15g once daily on non-dialysis days)