The decision was made due to substantially increased enrollment timelines and low event rates, respectively, which made it prohibitive to deliver study results within a timeframe to advance clinical practice meaningfully.
STABILIZE-CKD and DIALIZE-Outcomes trials are part of the CRYSTALIZE evidence program, which includes clinical and real-world evidence studies researching the potential benefit of Lokelma in the management of hyperkalemia (HK) across the cardiorenal spectrum.
Hyperkalemia is the medical term that describes a potassium level in blood that's higher than normal. Potassium is a chemical critical to the function of nerve and muscle cells, including in the heart.
The company will work with investigators to ensure the necessary follow-up with patients.
Lokelma is approved for a broad HK patient population in 56 countries worldwide. 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.
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