E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events

• Status: Completed
• Trial end date: 2012-04-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Cinacalcet; Cinacalcet Hydrochloride

Criteria

Inclusion Criteria:

• Inclusion:≥ 18 years of age

• Treated with maintenance hemodialysis - PTH ≥ 300 pg/mL (31.8 pmol/L)

• serum calcium ≥ 8.4mg/dL (2.1 mmol/L)

• Ca x P ≥ 45 mg2*/dL2 (3.63 mmol2/L2)

Exclusion Criteria: - Exclusion:

• Parathyroidectomy in the 12 weeks before the date of informed consent

• Received therapy with cinacalcet within 3 months of randomization

• Hospitalization within 12 weeks of randomization for any of the following events: a. Myocardial ischemia b. Unstable angina c. Heart Failure (HF) (including any unplanned presentation to a health care facility that would require mechanical intervention [i.e., unplanned dialysis treatment]) d. Peripheral vascular disease (other than dialysis vascular access revision) e. Stroke

• History of seizure within 12 weeks prior to randomization

• Scheduled date for kidney transplant from a known living donor

• Anticipated parathyroidectomy within 6 months after randomization

• in all instances, the 2 refers to squared.