EVOLVE - Evaluation Of Cinacalcet HCl Therapy to Lower Cardiovascular Events - EVOLVE

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3800

Inclusion Criteria

Men or women = 18 years of age at screening.
Treated with maintenance hemodialysis 3 times a week for = 3 months before randomization.
PTH obtained from the central laboratory must be = 300 pg/mL (31.8 pmol/L).
Serum calcium obtained from the central laboratory must be = 8.4 mg/dL (2.1 mmol/L).
Ca x P obtained from the central laboratory must be = 45 mg2/dL2 (3.63 mmol2/L2).
In the investigator’s opinion, the subject is likely to be available during the follow up phase of the study.
Agree to be followed for study endpoints until the end of study.
Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 13.1).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be ineligible for the study if they:

Have an unstable medical condition in the judgment of the investigator.
Parathyroidectomy in the 12 weeks before the date of informed consent.
Severe (ie, life-limiting) concomitant disease, including life-threatening malignancy or acquired immune deficiency syndrome (if likely to reduce life expectancy to less than 5 years), or any other life-threatening concomitant disease. Subjects with excised superficial lesions (eg, basal cell and squamous cell carcinoma of the skin) may be included.
Received therapy with cinacalcet within 3 months of randomization.
Hospitalization within 12 weeks of randomization for any of the following events:
a. Myocardial infarction
b. Unstable angina
c. Heart failure (including any unplanned presentation to a health care facility that would require mechanical intervention [ie, unplanned dialysis treatment])
d. Peripheral vascular disease (other than for 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.
General:
- Other investigational procedures are excluded.
- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
- Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study.
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
- Subject is pregnant, is breast feeding, or is of child-bearing potential and not using adequate contraceptive precautions.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method