EVOLVE Evaluation of Cinacalcet HCI Therapy to lower CardioVascular events. - EVOLVE

Conditions: Subjects with chronic kidney disease CKD receiving maintenance hemodialysis.
MedDRA version: 9.1Level: LLTClassification code 10020708Term: Hyperparathyroidism secondary

Registration Number: EUCTR2006-002075-40-IT

Lead Sponsor: AMGEN S.P.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3800

Inclusion Criteria

The following is a list of the key inclusion criteria 18 years of age 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 8.4mg/dL 2.1 mmol/L Ca x P obtained from the central laboratory must be 45 mg2/dL2 3.63 mmol2/L2 .
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

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 a. MI b. Unstable angina c. HF 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.