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Amgen Announces Top-Line Results Of Phase 3 Sensipar®/Mimpara® EVOLVE™ Trial
Date:6/8/2012

econdary HPT in patients with CKD receiving dialysis.

EVOLVE Trial Design

EVOLVE was an international, randomized, double-blind, placebo-controlled Phase 3 study of 3,883 patients with secondary HPT and CKD receiving dialysis. The trial, the largest of its kind in patients with CKD receiving dialysis, was designed to determine if treatment with Sensipar/Mimpara, compared to placebo, decreases the risk of all-cause mortality and CV morbidity. The trial consisted of a 30-day screening phase, a titration phase with visits every 2 weeks, and a follow-up phase with visits every 8 weeks. Following the screening phase, patients were randomized to the Sensipar/Mimpara or placebo groups. Possible sequential doses of Sensipar/Mimpara or placebo included 30, 60, 90, 120, and 180 mg. Flexible use of traditional therapies, such as vitamin D derivatives and phosphate binders, were permitted in both groups. 

About Secondary Hyperparathyroidism

Secondary hyperparathyroidism (HPT) is a common and serious condition that is often progressive among patients with CKD and it affects many of the approximately two million people throughout the world who are receiving dialysis. The disorder develops early as an adaptive response to declining kidney function when the parathyroid glands (four small glands in the neck) increase the production of parathyroid hormone (PTH) in an effort to maintain normal levels of calcium and phosphorus. Ultimately, excess PTH production proves inadequate for maintaining normal serum calcium and phosphorous levels. When kidney disease progresses to the point where dialysis is needed to sustain life, secondary HPT manifests as elevated PTH, calcium and phosphorus levels that, in turn, can lead to significant clinical consequences, including bone loss, skeletal fracture, and soft-tissue calcification. Although many patients with secondary HPT are not overtly symptomatic, bone pain, particularly when standi
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