According to a story from BioPortfolio, the biopharmaceutical company AstraZeneca recently announced the release of positive results from a phase 3b clinical trial. This trial was testing the safety and effectiveness of the company’s drug LOKELMA as a treatment for hyperkalemia, a condition of elevated potassium in the blood, in patients with end stage renal disease. These patients were also undergoing hemodialysis treatments. Patients with this disease are at an elevated risk of hyperkalemia.
Hyperkalemia, or elevated levels of blood potassium, does not necessarily cause symptoms, but when it reaches a certain level, it can become an urgent medical complication. Hyperkalemia rarely appears entirely on its own, and is often the result of other medical problems, such as kidney failure. Metabolic acidosis is another possible cause. Certain medications can also increase potassium concentrations in the blood. Symptoms of this condition include hyperventilation, malaise, heart palpitations, muscle weakness, muscle pain, and loss of sensation. Heart rhythm changes which occasionally appear can be potentially fatal. The condition can be managed with a low sodium diet, certain medications, and, when severe, dialysis. Hyperkalemia increases the overall risk of death ten-fold and can complicate the treatment of the underlying medical problem. To learn more about hyperkalemia, click here.
About The Trial
The trial demonstrated that LOKELMA was significantly more effective in controlling hyperkalemia when compared to placebo. 41.2 percent of patients that were treated with the drug during the trial could maintain normal levels of potassium for at least 3/4ths of their dialysis treatments, meaning that they did not need urgent rescue therapy. Meanwhile, just one percent of the placebo group would maintain normal levels.
The findings from the trial were first presented at this year’s European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress. These positive results indicate the LOKELMA could address this high unmet need for controlling hyperkalemia in this group of patients. LOKELMA has already been approved as a treatment for the condition, but the results from this trial support a new dosing regimen as used in the study.
These results are good news for the approximately two million end stage renal disease patients around the world that face an increased risk of life-threatening hyperkalemia.