The decision was made due to substantially increased enrolment timelines and low event rates, respectively, which made it prohibitive to deliver study results within a timeframe to meaningfully advance clinical practice.
STABILIZE-CKD and DIALIZE-Outcomes trials are part of the CRYSTALIZE evidence programme, which includes clinical and real-world evidence studies researching the potential benefit of Lokelma in the management of hyperkalaemia (HK) across the cardiorenal spectrum.
The Company will work with investigators to ensure the necessary follow-up with patients.
Lokelma is approved for the treatment of 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.
Notes
Hyperkalaemia
Hyperkalemia (HK) can be a chronic condition characterised by high levels of potassium in the blood, generally defined as greater than 5 mmol/L.1,2 Patients with high potassium levels are at significant risk of cardiac arrhythmias, which can lead to cardiac arrest.3 Worldwide there are about 840 million and 64 million people living with CKD and HF respectively, who are at an estimated two to three times higher risk of hyperkalemia.4-7
STABILIZE-CKD
STABILIZE-CKD is a Phase III randomised double-blind, placebo-controlled, multicentre study evaluating the effect of Lokelma, as an adjunct to optimised
DIALIZE-Outcomes
DIALIZE-Outcomes is a Phase III randomised, double-blind, placebo-controlled, multicentre study evaluating the effect of Lokelma on arrhythmia-related cardiovascular outcomes in patients on chronic haemodialysis with recurrent HK.14 The study involves approximately 2800 participants across the world.
Lokelma
Lokelma (sodium zirconium cyclosilicate) is an anti-hyperkalaemia (HK) therapy that provides rapid potassium reduction and sustained potassium control.15 It is indicated for the treatment of HK in adults, including patients with ESKD on chronic haemodialysis.16 It is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing medicine.16 It is administered orally and is odourless, tasteless, and stable at room temperature.16-17 Lokelma has been approved in more than 56 countries including US, EU,
Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of
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