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Phase III results from AstraZeneca

Elisabeth Bjork

The company has presented results from its HARMONIZE Global Phase III trial, which investigated the safety and efficacy of Lokelma (sodium zirconium cyclosilicate) vs. placebo in patients with hyperkalaemia in Japan, Korea, Taiwan and Russia.

HARMONIZE Global is a randomised, multicentre, double-blinded, placebo-controlled trial involving 267 patients with hyperkalaemia (mean potassium levels greater than 5.0 mEq/L) in 47 study locations across the Asia Pacific region. Patients who achieved normokalaemia (mean potassium levels of 3.5-5.0 mEq/L) during the first 48 hours with Lokelma 10g three times daily (93%; n=248) progressed to the 28-day maintenance phase of the trial. Patients in the maintenance phase were randomised 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.

Positive results

“The positive results of HARMONIZE Global add to the growing body of evidence supporting the use of Lokelma for adults with hyperkalaemia, a serious condition associated with chronic kidney disease, heart failure and diabetes as well as the use of renin-angiotensin-aldosterone system inhibitors. Through our robust clinical programme we are committed to assessing the potential of Lokelma in the broadest range of patient populations possible, including markets with high unmet medical need,” said Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development, AstraZeneca.

Lokelma is currently approved for the treatment of hyperkalaemia in adult patients in the US and the EU. Registrations in other markets are planned. Data from the HARMONIZE Global Phase III trial will support registration in Japan, Korea, Taiwan and Russia.

The results were presented at the American Society of Nephrology (ASN) Kidney Week 2018, San Diego, California, US.

Photo of Elisabeth Björk: AstraZeneca