AstraZeneca has announced a statistically significant and clinically meaningful improvement from its Phase IIIb DIALIZE trial, investigating the efficacy and safety of Lokelma (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia in patients with end-stage renal disease (ESRD) on haemodialysis.
In the trial, 41.2% of patients with hyperkalaemia on stable haemodialysis receiving Lokelma maintained pre-dialysis normal potassium levels (4-5 mmol/L) on at least three out of four dialysis treatments after the long interdialytic interval and did not require urgent rescue therapy, compared to 1.0% of patients receiving placebo.
The safety profile observed in the trial was also consistent with previous trials.
The results were presented at the 56th European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress in Budapest, Hungary and were published in the Journal of the American Society of Nephrology.
The drug is a highly-selective, oral potassium-removing agent currently approved and available in the US and EU for the treatment of adults with hyperkalaemia. Data from the DIALIZE trial will support label updates in the US and EU as the dosing regimen used in the trial is not currently approved.
Elisabeth Björk, senior vice president, said that the positive results show that “Lokelma can normalise potassium levels in between dialysis sessions for patients with hyperkalaemia who have end-stage renal disease. There is a high unmet treatment need that affects a large patient population and we believe Lokelma can play a critical role.”
Patients were randomised to receive Lokelma or placebo once daily on non-dialysis days for a treatment period of eight weeks. This included a four-week dose adjustment phase, starting at 5g and titrated weekly in 5g increments up to a maximum of 15g, and a four-week evaluation phase on stable dose.