Amgen launches further CV endpoint in EVOLVE, the largest ever Ph III CKD trial

Amgen, the California, USA-based biotechnology company, is poised to begin EVOLVE, a major international Phase III trial in chronic kidney disease patients, which intends to demonstrate whether Mimpara/Sensipar (cinacalcet), its calcimimetic treatment for secondary hyperparathyroidism (SHPT), can reduce cardiovascular (CV) mortality and non-fatal events .

The trial was announced in Glasgow, Scotland, during ERA-EDTA, the joint meeting of the European renal and dialysis/transplant associations. Describing the trial, Jurgen Floege of Germany's University of Aachen, said a large prospective study is needed to prove that the apparent beneficial effects of cinacalcet observed on laboratory values for parathyroid hormone, calcium and phosphate levels really do translate to better CV outcomes. "We're all waiting for the study to provide the definitive answer," he told doctors attending an Amgen-sponsored symposium.

The first-in-class treatment, first marketed only 18 months ago, works by binding to calcium receptors on the parathyroid gland and signalling to reduce output of parathyroid hormone (PTH). The downstream effect of less PTH is a reduction in the leaching of calcium and phosphorous from bones, fewer fractures, lower blood levels of the two minerals to within the ideal range and less likelihood of calcification occurring in the heart muscle, valves and blood vessels. "Calcification may relate to the most frequent cause of death among dialysis patients which is sudden cardiac death," he explained.