Status:
COMPLETED
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
Lead Sponsor:
Amgen
Conditions:
Secondary Hyperparathyroidism
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hyp...
Detailed Description
Secondary HPT is common in people with CKD. Patients with secondary HPT often have high parathyroid hormone (PTH) levels and may develop large parathyroid glands in the neck. Patients with secondary H...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 22 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2012
Estimated Enrollment :
3883 Patients enrolled
Trial Details
Trial ID
NCT00345839
Start Date
August 22 2006
End Date
April 10 2012
Last Update
November 7 2022
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