AstraZeneca (NASDAQ:AZN) is discontinuing two late-stage trials evaluating the potential benefits of its anti-hyperkalaemia drug, Lokelma (sodium zirconium cyclosilicate), across the cardiorenal spectrum.
Approved in more than 56 countries including the U.S. and EU, Lokelma is indicated for the treatment of hyperkalaemia in adults, including patients with end-stage kidney disease on chronic haemodialysis. The therapy is said to provide rapid potassium reduction and sustained potassium control.
The STABILIZE-CKD and DIALIZE-Outcomes Phase III evidence trials for the drug are being discontinued due to substantially increased enrolment timelines and low event rates, respectively.
“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,” the drugmaker said in a statement.
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 hyperkalaemia across the cardiorenal spectrum.