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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00345839
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : January 22, 2014
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE June 27, 2006
First Posted Date  ICMJE June 29, 2006
Results First Submitted Date  ICMJE June 6, 2013
Results First Posted Date  ICMJE January 22, 2014
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE August 22, 2006
Actual Primary Completion Date April 10, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2006)
Time to the composite event comprising all-cause mortality or non-fatal cardiovascular events (MI, hospitalization for unstable angina, HF, or peripheral vascular event)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Time to Parathyroidectomy. Stratified by history of diabetes and country.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
Official Title  ICMJE EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
Brief 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.
Detailed Description 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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Secondary Hyperparathyroidism
  • Chronic Kidney Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Cinacalcet
    Intervention: Drug: Cinacalcet
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2008)
3883
Original Enrollment  ICMJE
 (submitted: June 28, 2006)
3800
Actual Study Completion Date  ICMJE April 10, 2012
Actual Primary Completion Date April 10, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Denmark,   France,   Germany,   Hungary,   Ireland,   Italy,   Mexico,   Netherlands,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00345839
Other Study ID Numbers  ICMJE 20050182
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2019

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