Positive results from a Phase III HARMONIZE Global clinical trial, evaluating hyperkalemia drug Lokelma (sodium zirconium cyclosilicate) in patients in Japan, Korea, Taiwan and Russia, were presented at Kidney Week in San Diego by Anglo-Swedish pharma major AstraZeneca (LSE: AZN).
HARMONIZE Global is a randomized, multicenter, double-blinded, placebo-controlled trial involving 267 patients with hyperkalemia (mean potassium levels greater than 5.0 mEq/L) in 47 study locations across the Asia Pacific region. Patients who achieved normokalemia (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 randomized to receive Lokelma 5g or 10g, or placebo, administered once daily. Results show normokalemia was maintained with statistically-significant differences observed, irrespective of dose, for Lokelma versus 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.
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