Phase 3
Completed N=3,883
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
Source: ClinicalTrials.gov NCT00345839 ↗Enrolled (actual)
3,883
Serious AEs
69.7%
Results posted
Jan 2014
Primary outcomePrimary: Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event) — 55.0; 53.0 Months — p=0.112
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event) |
55.0; 53.0 | 0.112 |
| SECONDARY Time to All-cause Mortality |
NA; NA | 0.249 |
| SECONDARY Time to Myocardial Infarction |
NA; NA | 0.800 |
| SECONDARY Time to Hospitalization for Unstable Angina |
NA; NA | 0.283 |
| SECONDARY Time to Heart Failure |
NA; NA | 0.034 sig |
| SECONDARY Time to Peripheral Vascular Event |
NA; NA | 0.190 |
| SECONDARY Time to Cardiovascular Mortality |
NA; NA | 0.277 |
| SECONDARY Time to Stroke |
NA; NA | 0.607 |
| SECONDARY Time to Bone Fracture |
NA; NA | 0.218 |
| SECONDARY Time to Parathyroidectomy |
NA; NA | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria: - 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.
Data sourced from ClinicalTrials.gov (NCT00345839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.