Update on CRYSTALIZE evidence trials for Lokelma (sodium zirconium cyclosilicate) for hyperkalaemia
AstraZeneca has decided to discontinue the STABILIZE-CKD and DIALIZE-Outcomes Phase III evidence trials for Lokelma (sodium zirconium cyclosilicate)
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.
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D said: “Our ambitious CRYSTALIZE programme continues to generate evidence to improve the current management of hyperkalaemia, which we believe leads to better outcomes for cardiorenal patients when a potassium binder is included in their treatment regimen. Lokelma is the leading branded potassium binder globally and continues to benefit a broad hyperkalaemia patient population to achieve rapid, sustained potassium control and is well tolerated.”
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.
Related news and insights
SeaStar Medical Holding Corporation announces that the FDA has granted a Humanitarian Device Exemption (HDE) Approval Order to the Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy (KRT)
Protagonist Therapeutics, Inc. announced publication in the New England Journal of Medicine (NEJM) of the REVIVE Phase II study (NCT04057040) results evaluating the efficacy and safety of rusfertide in polycythemia vera (PV), a myeloproliferative neoplasm affecting approximately 160,000 patients in the United States (US)