(CercleFinance.com) – AstraZeneca announced the termination of the STABILIZE-CKD and DIALIZE-Outcomes phase III trials for Lokelma (sodium zirconium cyclosilicate).
This decision was made due to a significant increase in registration times and the low rate of events. The laboratory believes that these elements made it impossible to provide the results of the study within a time frame allowing significant progress in clinical practice.
The STABILIZE-CKD and DIALIZE-Outcomes trials are part of the CRYSTALIZE evidence program, which includes clinical studies and real-world evidence examining the potential benefits of Lokelma in the management of hyperkalemia across the cardio-renal spectrum.
Despite the cessation of trials, Lokelma is still approved for the treatment of a large population of patients with hyperkalemia in 56 countries.
AstraZeneca clarifies that this decision is not the result of safety concerns, and the positive benefit-risk ratio of Lokelma does not change in the approved indication.
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