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

This study will evaluate the effects of cinacalcet (cincalcet HCl or Sensipar/Mimpara) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathryoidism (HPT) who are receiving dialysis.

Official Title

EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events

Conditions

Secondary Hyperparathyroidism, Chronic Kidney Disease

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Time to the composite event comprising all-cause mortality or non-fatal cardiovascular events (MI, hospitalization for unstable angina, HF, or peripheral vascular event)

Secondary Outcome Measures:

• Time to all-cause mortality
• Time to cardiovascular mortality
• Time to fatal and non-fatal MI
• Time to fatal and non-fatal hospitalization for unstable angina
• Time to fatal and non-fatal HF event
• Time to fatal and non-fatal peripheral vascular event
• Time to fatal and non-fatal stroke
• Time to bone fracture
• Time to parathyroidectomy

Study Start

September 2006; Expected completion: August 2010

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• > 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:

• 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: Myocardial ischemia; unstable angina; HF (including any unplanned presentation to a health care facility that would require mechanical intervention [i.e., unplanned dialysis treatment]); Peripheral vascular disease (other than dialysis vascular access revision); 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

Total Enrolment

3800

Contact Details

Australian Locations:

• Research Site, Hobart, Australia; Recruiting
• Research Site, Heidelberg, Australia; Recruiting
• Research Site, Herston, Australia; Recruiting
• Research Site, Woolloongabba, Australia; Recruiting
• Research Site, Fremantle, Australia; Recruiting
• Research Site, Launceston, Australia; Recruiting
• Research Site, Clayton, Australia; Recruiting
• Research Site, Garrant, Australian Capital Territory, Australia; Recruiting
• Research Site, Liverpool, New South Wales, Australia; Recruiting
• Research Site, St. Leonards, New South Wales, Australia; Recruiting
• Research Site, Gosford, New South Wales, Australia; Recruiting
• Research Site, Randwick, New South Wales, Australia; Recruiting
• Research Site, Hunter Regional Mail Exchange, New South Wales, Australia; Recruiting
• Research Site, Wollongong, New South Wales, Australia; Recruiting
• Research Site, Woodville, South Australia, Australia; Recruiting
• Research Site, Adelaide, South Australia, Australia; Recruiting

For more information, refer to Amgen Trials

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