Amgen to study cardiovascular effects of Sensipar/Mimpara on hyperparathyroidism patient with kidney disease

By E. Janene Geiss

Philadelphia, July 17 - Amgen announced Monday the start of the largest prospective, randomized clinical trial planned to date in patients with stage five chronic kidney disease.

Evaluation of Cinacalcet Therapy to Lower CardioVascular Events, or Evolve, is a phase 3 international clinical outcomes study designed to determine whether Sensipar/Mimpara (cinacalcet Hcl) can effectively reduce the risk of mortality and cardiovascular morbidity in patients with secondary hyperparathyroidism and chronic kidney disease undergoing maintenance dialysis, according to a company news release.

The trial was announced at the 2006 European Renal Association - European Dialysis and Transplant Association, officials said. Cinacalet Hcl is marketed as Sensipar in the United States, Canada and Australia and as Mimpara in the European Union.

Amgen said its decision to begin the trial is supported by a recent post-hoc analysis of four pooled, prospective, randomized, placebo-controlled clinical trials that showed treatment with cinacalcet Hcl in patients with secondary hyperparathyroidism and chronic kidney disease receiving dialysis resulted in improvement of clinical outcomes, including cardiovascular hospitalization, parathyroidectomy, fracture and health-related quality of life.

The trial is expected to enroll about 3,800 patients in 500 clinical sites throughout the world, including the United States, Latin America, Canada, Australia, Russia and the European Union.

Amgen said it has gained acceptance of the study design with global regulatory authorities and enrollment is expected to begin in the second half of 2006.

Amgen said it has begun an extensive clinical trials program to study the effect of treating chronic kidney disease complications or anemia on cardiovascular outcomes in different populations.

In addition to Evolve, Amgen started Treat, a trial to reduce cardiovascular events with Aranesp therapy, which is an ongoing trial in diabetic patients with chronic kidney disease and anemia not requiring dialysis. It also initiated the RED-HF trial (Reduction of Events with Darbepoetin alfa in Heart Failure) to evaluate treatment of anemia with Aranesp on morbidity and mortality in patients with symptomatic heart failure.

Amgen is a Thousand Oaks, Calif., biotechnology company.

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