At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓On maintenance hemodialysis with PTH ≥300 pg/mL
- ✓Serum calcium ≥8.4 mg/dL
- ✓Calcium-phosphorus product ≥45 mg²/dL²
- ✕Parathyroidectomy within 12 weeks before informed consent
- ✕Prior cinacalcet use within 3 months of randomization
- ✕Hospitalization within 12 weeks for myocardial ischemia, unstable angina, heart failure, peripheral vascular disease, or stroke
- ✕Seizure history within 12 weeks prior to randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
In Brief
A Phase 3 clinical trial evaluating Cinacalcet and Placebo for Secondary Hyperparathyroidism and Chronic Kidney Disease. Completed, enrolled 3,883 participants.
Detailed 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 hyperparathyroidism (HPT) who are receiving dialysis.
Study Details
Timeline
Interventions
Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg daily (QD), once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.
Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg QD, once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.