Two post-approval outcome trials of anti-hyperkalemia drug stopped for logistical reasons
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Key takeaways:
- Two post-approval studies of the anti-hyperkalemia drug sodium zirconium cyclosilicate have been stopped for low enrollment and event rates.
- The studies would have assessed heart- and kidney-related outcomes.
AstraZeneca announced that two post-approval randomized heart- and kidney-related outcome studies of its anti-hyperkalemia drug have been stopped due to slow enrollment and low event rates.
The drug, sodium zirconium cyclosilicate (Lokelma), was approved in 2018 for prevention of hyperkalemia in patients with chronic kidney disease (CKD) and in those with HF taking renin-angiotensin-aldosterone system (RAAS) inhibitors, which can raise potassium levels.
The phase 3 post-approval trials stopped were STABILIZE-CKD and DIALIZE-Outcomes.
STABILIZE-CKD was designed to evaluate the effect of sodium zirconium cyclosilicate on CKD progression in patients with CKD and with or at risk for hyperkalemia taking a RAAS inhibitor. It was stopped due to “substantially increased enrollment timelines,” according to a press release issued by AstraZeneca.
DIALIZE-Outcomes was designed to evaluate the effect of sodium zirconium cyclosilicate on arrhythmia-related CV outcomes in patients on chronic hemodialysis with recurrent hyperkalemia. It was stopped due to low event rates, according to the release.
The issues with enrollment and event rates “made it prohibitive to deliver study results within a timeframe to meaningfully advance clinical practice,” the company stated in the release. “The decision to discontinue the trials is not due to safety concerns and the positive benefit-risk of Lokelma does not change in the approved indication.”
AstraZeneca will work with investigators to provide appropriate follow-up for the patients that were enrolled, according to the release.
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