Amgen announces international trial for dialysis drug

Amgen has started the largest prospective, randomised clinical trial in patients with stage five chronic kidney disease (CKD).

The trial is expected to enrol approximately 3,800 patients in 500 clinical sites around the world, including the UK and other EU. Patients will be treated with Mimpara (cinacalcet HCl) to find out whether it can effectively decrease mortality and cardiovascular morbidity in patients with CKD and hyperparathyroidism (HPT).

Amgen’s decision to initiate this new study – entitled EVOLVE – follows a successful trial of patients with HPT and CKD that showed an improvement in factors such as cardiovascular hospitalisation, parathyroidectomies, fractures and health-related quality of life.

William Dere, Amgen’s chief medical officer and vice-president for global development, stated: “Recent data have shown a relationship between poorly controlled secondary HPT and increased mortality and morbidity in CKD patients receiving dialysis.”

Dr Martin Wilkie of Northern General Hospital in Sheffield, remarked: “Use of Mimpara in dialysis patients enables patients and physicians to achieve greater control of secondary HPT, especially when adequate treatment is initiated in the early stages of this progressive metabolic disorder.

“In our study, we found that the greatest reductions in Calcium and Phosphate were in those patients receiving Mimpara in combination with lower doses of vitamin D sterols.”

“Furthermore, large Phase 3 outcomes clinical studies are needed to determine Mimpara’s benefits in improving patients’ lives and preventing disease progression,” he added.

NICE is currently appraising Mimpara for the treatment of secondary HPT in patients on maintenance dialysis. The second appraisal committee meeting is due on July 25th before guidance on the drug is issued.

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