E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events (EVOLVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00345839
First received: June 27, 2006
Last updated: July 11, 2014
Last verified: July 2014

June 27, 2006
July 11, 2014
August 2006
January 2012   (final data collection date for primary outcome measure)
Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event) [ Time Frame: From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.
Time to the composite event comprising all-cause mortality or non-fatal cardiovascular events (MI, hospitalization for unstable angina, HF, or peripheral vascular event)
Complete list of historical versions of study NCT00345839 on ClinicalTrials.gov Archive Site
  • Time to All-cause Mortality [ Time Frame: From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to All-cause Mortality. Stratified by history of diabetes and country.
  • Time to Myocardial Infarction [ Time Frame: From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Myocardial Infarction. Stratified by history of diabetes and country.
  • Time to Hospitalization for Unstable Angina [ Time Frame: From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country.
  • Time to Heart Failure [ Time Frame: From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Heart Failure. Stratified by history of diabetes and country.
  • Time to Peripheral Vascular Event [ Time Frame: From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Peripheral Vascular Event. Stratified by history of diabetes and country.
  • Time to Cardiovascular Mortality [ Time Frame: From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Cardiovascular Mortality. Stratified by history of diabetes and country.
  • Time to Stroke [ Time Frame: From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Stroke. Stratified by history of diabetes and country.
  • Time to Bone Fracture [ Time Frame: From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Bone Fracture. Stratified by history of diabetes and country.
  • Time to Parathyroidectomy [ Time Frame: From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Parathyroidectomy. Stratified by history of diabetes and country.
  • Time to all-cause mortality
  • Time to cardiovascular mortality
  • Time to fatal and non-fatal MI
  • Time to fatal and non-fatal hospitalization for unstable angina
  • Time to fatal and non-fatal HF event
  • Time to fatal and non-fatal peripheral vascular event
  • Time to fatal and non-fatal stroke
  • Time to bone fracture
  • Time to parathyroidectomy
Not Provided
Not Provided
 
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events

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.

Secondary HPT is common in people with CKD. Patients with secondary HPT often have high parathyroid hormone (PTH) levels and may develop large parathyroid glands in the neck. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. Other problems from secondary HPT may include increases in blood levels of calcium and phosphorus. These may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), or heart and lung problems. New evidence suggests that secondary HPT is associated with cardiovascular disease and increased death risk. The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events (having to do with the heart and its blood vessels) and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis. These events include death from any reason, heart attack and episodes where the heart does not get enough oxygen, peripheral vascular disease (narrowing of vessels that carry blood to the legs, arms, stomach or kidneys), and heart failure (a condition that occurs when the heart is unable to pump enough blood to meet the need's of the body's tissues)

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Secondary Hyperparathyroidism
  • Chronic Kidney Disease
  • Drug: Cinacalcet
    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.
  • Drug: Placebo
    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.
  • Experimental: Cinacalcet
    Intervention: Drug: Cinacalcet
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3883
May 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00345839
20050182
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP