AstraZeneca says Phase 3 HARMONIZE trial confirms efficacy of Lokelma
AstraZeneca presented the results from the HARMONIZE Global Phase 3 trial, which investigated the safety and efficacy of Lokelma vs. placebo in patients with hyperkalaemia in Japan, Korea, Taiwan and Russia. The results were presented at the American Society of Nephrology Kidney Week 2018, San Diego, California. Patients who achieved normokalaemia during the first 48 hours with Lokelma 10g three times daily progressed to the 28-day maintenance phase of the trial. Patients in the maintenance phase were randomized to receive Lokelma 5g or 10g, or placebo, administered once daily. Results show normokalaemia was maintained with statistically-significant differences observed, irrespective of dose, for Lokelma vs. placebo in terms of mean potassium levels during days 8-29 of the maintenance phase. The safety profile of Lokelma observed in HARMONIZE Global was consistent with previous trials.