EValuation Of Cinacalcet HCL Therapy to Lower CardioVascular Events

Phase 3

Completed

Conditions: overlijden (door welke oorzaak dan ook)
mortality and cardiovasculair morbidity
10019280
10029149

Registration Number: NL-OMON30733

Lead Sponsor: Amgen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 56

Inclusion Criteria

>= 18 years of age
treated with maintenance hemodialysis 3 times a week for >= 3 months before randomization
PTH >= 31.8 mmol/L
Ca >= 2.1 mmol/L
Ca x P >= 3.63 mmol/L

Exclusion Criteria

Parathyroidectomy in the 12 weeks prior to randomization
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
d. Peripheral vascular disease
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> Time to the composite event comprising all-cause mortality or non-fatal<br /><br>cardiovascular events (MI, hospitalization for unstable angina, HF, or<br /><br>peripheral vascular event) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p> • Time to all-cause mortality<br /><br>• Time to cardiovascular mortality<br /><br>• Time to fatal and non-fatal MI<br /><br>• Time to fatal and non-fatal hospitalization for unstable angina<br /><br>• Time to fatal and non-fatal HF event<br /><br>• Time to fatal and non-fatal peripheral vascular event<br /><br>• Time to fatal and non-fatal stroke<br /><br>• Time to bone fracture<br /><br>• Time to parathyroidectomy </p><br>