AstraZeneca Discontinues Two Clinical Trials for Lokelma
AstraZeneca has decided to discontinue two large Phase III clinical trials for its hyperkalemia drug Lokelma (sodium zirconium silicate). The decision was driven by substantially extended recruitment timelines and low event rates.
Pharmaceutical company AstraZeneca has opted to discontinue two extensive Phase III clinical trials, STABILIZE-CKD and DIALIZE-Outcomes, related to its hyperkalemia treatment Lokelma (sodium zirconium silicate). The company cites substantially increased patient enrollment timelines and low event rates as the primary reasons for the decision. These factors made it prohibitively difficult to deliver study results within a timeframe that could meaningfully advance clinical practice.
The STABILIZE-CKD and DIALIZE-Outcomes trials were part of the broader CRYSTALIZE evidence program, which explores the benefits of Lokelma in managing hyperkalemia, characterized by high potassium levels in the blood, for patients with cardiorenal conditions.
Lokelma is already approved in more than 50 countries for hyperkalemia treatment. AstraZeneca asserts that the discontinuation of these trials is not due to safety concerns, and the established benefit-risk profile of Lokelma remains unchanged for its approved indications.