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news.Amgen has initiated a large phase III study to evaluate its drug Sensipar in patients with stage-five chronic kidney disease.
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The study, known as EVOLVE, is a clinical outcomes study designed to determine whether Sensipar (cinacalcet HCl), marketed as Mimpara in Europe, can effectively reduce the risk of mortality and cardiovascular morbidity in patients with secondary hyperparathyroidism (secondary HPT) and chronic kidney disease (CKD) undergoing maintenance dialysis.
EVOLVE is expected to enroll approximately 3,800 patients in 500 clinical sites throughout the world, including the US, Latin America, Canada, Australia, Russia and the European Union. Amgen has gained acceptance of the study design with global regulatory authorities and enrollment is expected to begin in the second half of 2006.
“Recent data have shown a relationship between poorly controlled secondary HPT and increased mortality and morbidity in CKD patients receiving dialysis,” said Dr Willard Dere, senior vice president for global development and chief medical officer at Amgen. “Until EVOLVE, no robust prospective, clinical trial has definitively determined whether treating secondary HPT reduces the risk of cardiovascular events. The results of the EVOLVE will be invaluable to nephrologists in deciding how to optimally manage secondary HPT.”