AstraZeneca PLC (LSE:AZN) has announced the discontinuation of two phase III trials, STABILIZE-CKD and DIALIZE-Outcomes, for its drug Lokelma (sodium zirconium cyclosilicate).
This decision stems from logistical challenges, including extended timelines for patient enrolment and lower-than-expected occurrences of the conditions being studied.
These trials were integral to the CRYSTALIZE evidence programme, aimed at exploring the effectiveness of Lokelma in treating hyperkalaemia (HK) across various heart and kidney conditions. Hyperkalaemia refers to a higher-than-normal level of potassium in the blood, which can be detrimental to cardiac and renal health.
AstraZeneca said the discontinuation is not linked to any safety concerns regarding Lokelma. The drug is currently approved in 56 countries for treating a broad spectrum of patients with hyperkalaemia. The company's decision does not affect the existing positive benefit-risk assessment of Lokelma for its approved use.